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Sleep Program on Preterm Infants' Sleep, and Caregiver's Sleep, Stress, Quality of Life, and Attachment

3 maggio 2026 aggiornato da: Hsiang-Yun Lan, National Defense Medical Center, Taiwan

Construction and Longitudinal Following Up the Effects of Early Sleep Facilitation Program on Preterm Infants' Sleep, Health After Discharge, and Caregiver's Sleep, Stress, Quality of Life, and Attachment

This research plan to construct an "Early Sleep Facilitation Program"and to explore the effects of the "early sleep Facilitation program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.

The proposed study has six specific aims:

  1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
  2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
  3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
  4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
  5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
  6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Background and purpose:

Preterm infants need to receive intensive care in a neonatal intensive care unit (NICU) to survive, but the sleep of preterm infants is disturbed by the environment of the intensive care unit, invasive treatment and care activities. When a preterm infant's sleep is interrupted, it not only affects his physical growth, behavior and emotional development, but also affects his recovery from illness and the length of hospital stay, and even affects his sleep quality and development after returning home. However, medical personnel are busy with clinical practice, seldom pay attention to the sleep development of preterm infants. In the past, few studies paid attention to the factors that affect the sleep of preterm infants after returning home, and few studies also explored the sleep and physical and mental health of preterm infants and their main caregivers after returning home. Sleep intervention in preterm infants was mostly a single outcome indicator; besides, past studies lacked objective sleep instruments and long-term follow-up studies.

Based on the above research gaps, this research plan to construct an "early sleep Facilitation program" and to explore the effects of the "Early Sleep Facilitation Program" on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver for a Long-term follow-up research.

The proposed study has six specific aims:

  1. Explore the effect of "Early Sleep Facilitation Program" on the sleep of preterm infants during hospitalization and after returning home.
  2. Explore the effect of "Early Sleep Facilitation Program" on the health of preterm infants during hospitalization and after returning home.
  3. Explore the effect of "Early Sleep Facilitation Program" on the sleep of the caregiver after preterm infants during hospitalization and after returning home.
  4. Explore the effect of the "Early Sleep Facilitation Program" on the stress of the caregivers of preterm infants during hospitalization and after returning home.
  5. Explore the effect of "Early Sleep Facilitation Program" on the quality of life of the caregivers of preterm infants during hospitalization and after returning home.
  6. Explore the effect of "Early Sleep Facilitation Program" on the attachment of the caregivers of preterm infants during hospitalization and after returning home.

Methods:

This randomized controlled trial will adopt a longitudinal repeated measures design to examine the " Early Sleep Facilitation Program " on the sleep and health of preterm infants and the sleep, stress, quality of life and attachment of the caregiver. Preterm infants and the caregiver were recruited by convenience sampling in Neonatal Intensive Care Unit and Infant Intermediate Care Unit of a medical center in northern Taiwan from July in 2020 to December in 2022. There are two different intervention modes (intervention group and control group), the intervention group receives " Early Sleep Facilitation Program " and the control group receives routine care. The program is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status after the first month and the second month after discharge. The control group receives routine care and provide general discharge care and nursing guidance. The questionnaires and physiological measurements will be used to collect the data. The two groups will collect data during hospitalization, one week before discharge, and the first month and the second month after discharge. We will use generalized estimation equations method to analyze research data.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

86

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
      • Taipei, Taiwan
        • National defense medical center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 mesi a 8 mesi (Bambino)

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  1. Preterm infants gestational age (GA) > 28 weeks and < 37 weeks, and birth weight less than 2200 grams;
  2. The main caregiver of the preterm infants can communicate in Mandarin and Taiwanese;
  3. The parents of the preterm infants and their main caregivers agrees to participate in this research and signs the research consent form

Exclusion Criteria:

  1. Premature infant is diagnosed with limb dysfunction or brain neuropathy, such as: third or fourth degree intraventricular hemorrhage or peripheral ventricular leukomalacia;
  2. Other diseases that affect sleep, such as: congenital nerve development Abnormalities, epilepsy;
  3. Those who need to take muscle relaxants, sedatives or bronchodilators

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Early Sleep Facilitation Program
Perform sleep circadian rhythm training during hospitalization, and provide caregivers with nursing guidance to promote sleep of premature infants before discharge
Comportamentale: Early Sleep Facilitation Program
It is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status within two months after discharge.
Altro: Routine care
Receives routine care and provide general discharge care and nursing guidance.
Comparatore attivo: routine care and provide general discharge care and nursing guidance
Routine care and provide general discharge care and nursing guidance.
Altro: Routine care
Receives routine care and provide general discharge care and nursing guidance.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Preterm Infants' Sleep- Actigraphy -T1
Lasso di tempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Accessed by Actigraphy
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Sleep- Actigraphy -T2
Lasso di tempo: T2- preterm infants one week before discharge
Accessed by Actigraphy
T2- preterm infants one week before discharge
Preterm Infants' Sleep- Actigraphy -T3
Lasso di tempo: T3- preterm infants the first month after discharge
Accessed by Actigraphy
T3- preterm infants the first month after discharge
Preterm Infants' Sleep- Actigraphy -T4
Lasso di tempo: T4- preterm infants second month after discharge
Accessed by Actigraphy
T4- preterm infants second month after discharge
Preterm Infants' Sleep- sleep log -T1
Lasso di tempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Sleep- sleep log -T2
Lasso di tempo: T2- preterm infants one week before discharge
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
T2- preterm infants one week before discharge
Preterm Infants' Sleep- sleep log -T3
Lasso di tempo: T3- preterm infants the first month after discharge
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
T3- preterm infants the first month after discharge
Preterm Infants' Sleep- sleep log -T4
Lasso di tempo: T4- preterm infants second month after discharge
The primary caregiver records the sleep log of premature babies. The sleep log is used to understand the total sleep hours of premature infants, the number of awake hours/times at night, sleep efficiency, and factors that may interfere with sleep.
T4- preterm infants second month after discharge
Preterm Infants' Health- Health Assessment Form-weight-T1
Lasso di tempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Health- Health Assessment Form-weight-T2
Lasso di tempo: T2- preterm infants one week before discharge

The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T2- preterm infants one week before discharge
Preterm Infants' Health- Health Assessment Form-weight-T3
Lasso di tempo: T3- preterm infants the first month after discharge

The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T3- preterm infants the first month after discharge
Preterm Infants' Health- Health Assessment Form-weight-T4
Lasso di tempo: T4- preterm infants second month after discharge

The weight is measured by the researcher with a baby weight scale. This device record data: weight(kg).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T4- preterm infants second month after discharge
Preterm Infants' Health- Health Assessment Form- head circumference-T1
Lasso di tempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention

The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Health- Health Assessment Form- head circumference-T2
Lasso di tempo: T2- preterm infants one week before discharge

The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T2- preterm infants one week before discharge
Preterm Infants' Health- Health Assessment Form- head circumference-T3
Lasso di tempo: T3- preterm infants the first month after discharge

The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T3- preterm infants the first month after discharge
Preterm Infants' Health- Health Assessment Form- head circumference-T4
Lasso di tempo: T4- preterm infants second month after discharge

The head circumference is measured by the researcher with tape measure. This device record data: head circumference (cm).

Health Assessment Form for premature infants information included anthropometric measurements: size at weight (kg), head circumference (cm), and recumbent length (cm) with the new World Health Organization (WHO) Growth Standard for a growth chart. Calculate Growth curve and Growth percentage.
T4- preterm infants second month after discharge
Preterm Infants' Health- Nutrition data-T1
Lasso di tempo: T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
T1-baseline collect preterm infants after 32 weeks of gestation before intervention
Preterm Infants' Health- Nutrition data-T2
Lasso di tempo: T2- preterm infants one week before discharge
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
T2- preterm infants one week before discharge
Preterm Infants' Health- Nutrition data-T3
Lasso di tempo: T3- preterm infants the first month after discharge
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
T3- preterm infants the first month after discharge
Preterm Infants' Health- Nutrition data-T4
Lasso di tempo: T4- preterm infants second month after discharge
Data on nutrition support included: recordings of types of feeding (breast milk or formula), total fluid intakes, and number of feeding interruptions.
T4- preterm infants second month after discharge
Caregivers' Sleep- Actigraphy-T1
Lasso di tempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Sleep- Actigraphy-T2
Lasso di tempo: T2- preterm infants one week before discharge
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
T2- preterm infants one week before discharge
Caregivers' Sleep- Actigraphy-T3
Lasso di tempo: T3- preterm infants the first month after discharge
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
T3- preterm infants the first month after discharge
Caregivers' Sleep- Actigraphy-T4
Lasso di tempo: T4- preterm infants second month after discharge
Accessed by Actigraphy. Actigraphy is a validated method of objectively measuring sleep parameters and average motor activity.
T4- preterm infants second month after discharge
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T1
Lasso di tempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T2
Lasso di tempo: T2- preterm infants one week before discharge
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
T2- preterm infants one week before discharge
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T3
Lasso di tempo: T3- preterm infants the first month after discharge
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
T3- preterm infants the first month after discharge
Caregivers' Sleep- Pittsburgh Sleep Quality Index (PSQI)-T4
Lasso di tempo: T4- preterm infants second month after discharge
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
T4- preterm infants second month after discharge
Caregivers' Sleep- Sleep log-T1
Lasso di tempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Sleep- Sleep log-T2
Lasso di tempo: T2- preterm infants one week before discharge
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
T2- preterm infants one week before discharge
Caregivers' Sleep- Sleep log-T3
Lasso di tempo: T3- preterm infants the first month after discharge
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
T3- preterm infants the first month after discharge
Caregivers' Sleep- Sleep log-T4
Lasso di tempo: T4- preterm infants second month after discharge
Sleep log: record the sleep time and sleep status of the previous day to understand the total sleep hours, the number of awake hours/times at night, sleep efficiency, and whether there are events that affect the mood of falling asleep, medication or physical discomfort, whether to consume irritating substances and alcohol, etc. And use a scale of 1 to 5 points to assess the quality of sleep the night before and the level of wakefulness when waking up.
T4- preterm infants second month after discharge
Caregivers' Stress- T1
Lasso di tempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' Stress- T2
Lasso di tempo: T2- preterm infants one week before discharge
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
T2- preterm infants one week before discharge
Caregivers' Stress- T3
Lasso di tempo: T3- preterm infants the first month after discharge
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
T3- preterm infants the first month after discharge
Caregivers' Stress- T4
Lasso di tempo: T4- preterm infants second month after discharge
Parenting Stress Index-Third Edition short form (PSI-SF) The PSI Short Form is a direct derivative of the full-length test and consists of a 36-item self-scoring questionnaire/profile. Each question is based on Likert's five-point. The total score is between 36-180 points, the higher the score, the greater the parental pressure.
T4- preterm infants second month after discharge
Caregivers' quality of life-T1
Lasso di tempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' quality of life-T2
Lasso di tempo: T2- preterm infants one week before discharge
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
T2- preterm infants one week before discharge
Caregivers' quality of life-T3
Lasso di tempo: T3- preterm infants the first month after discharge
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
T3- preterm infants the first month after discharge
Caregivers' quality of life-T4
Lasso di tempo: T4- preterm infants second month after discharge
World Health Organization Quality of Life-BREF (WHOQOL-BREF) The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. There are 28 questions in the questionnaire. The content includes four aspects: physical health, psychology, social relations and environment. Each question is based on Likert's five-point. The higher the score, the better the quality of life.
T4- preterm infants second month after discharge
Caregivers' attachment-T1
Lasso di tempo: T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention

Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.

The higher the total score, the closer the maternal-infant attachment.
T1-baseline collect Caregiver of preterm infants after 32 weeks of gestation before intervention
Caregivers' attachment-T2
Lasso di tempo: T2- preterm infants one week before discharge

Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.

The higher the total score, the closer the maternal-infant attachment.
T2- preterm infants one week before discharge
Caregivers' attachment-T3
Lasso di tempo: T3- preterm infants the first month after discharge

Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.

The higher the total score, the closer the maternal-infant attachment.
T3- preterm infants the first month after discharge
Caregivers' attachment-T4
Lasso di tempo: T4- preterm infants second month after discharge

Maternal Attachment Inventory (MAI) The Maternal Attachment Inventory(MAI) has 26 questions on the scale. The questions use a response level of 1 to 4. The 1 point means almost none, 2 points means occasionally, 3 points means often, and 4 points means almost often.

The higher the total score, the closer the maternal-infant attachment.
T4- preterm infants second month after discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Defense Medical Center, Taiwan

Investigatori

  • Investigatore principale: Hsiang-Yun Lan, Asst. Prof., National Defense Medical Center, Taiwan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2020

Completamento primario (Effettivo)

1 dicembre 2022

Completamento dello studio (Effettivo)

30 novembre 2023

Date di iscrizione allo studio

Primo inviato

28 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

12 giugno 2021

Primo Inserito (Effettivo)

18 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • C202005014

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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