- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05333653
Supportive Care During Childbirth and Well-being
The Effect of Continous Supportive Care at Childbirth on Maternal Psychological Well-being: A Single-blind Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mersin, Turkey, 33180
- Gozde Gokce Isbir
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The ages of 18-40 women,
- At least primary school graduate,
- Mother tongue Turkish,
- Single fetus,
- Term,
- Spontaneous birth,
- Cervical dilatation between 0-6 cm (latent phase) and without a condition that could prevent vaginal delivery.
- Primiparous and multiparous women
- Not have any disease or complication and agreed to participate in the study were included.
Exclusion Criteria:
- Women who developed a complication with the fetus or themselves during delivery,
- Underwent emergency cesarean section,
- Not be reached during follow-ups by telephone,
- Wanted to withdraw from the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Continous Supportive Care
Participants were provided care in different rooms, blinded to the differences in practice used between the two groups.
In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created.
In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences.
|
Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences. Participants in the control group, on the other hand, received routine care given in the hospital by other midwives in the clinic. |
EXPERIMENTAL: Control
Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes.
The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
|
Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes.
The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear of Childbirth (DFS)
Time Frame: through delivery, an average of 24th hours
|
Women's fears at the time of birth were evaluated with the Delivery fear scale (DFS). This scale was developed by Wijma et al (2002) for fear during delivery. The Turkish validity and reliability of the scale were performed by Sercekus et al. (2017). This scale consisting of 10 items is a 10-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 10 to 100. The scale has no cutoff score, and high scores indicated higher fear. |
through delivery, an average of 24th hours
|
Perceived control and support in birth (SCIB)
Time Frame: Postpartum 24th hours
|
Women's perceptions of support and control at the time of birth were evaluated with the Perceived control and support in birth scale. SCIB was developed by Ford et al., (2009) to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed by Inci et al. (2015). This scale consisting of 33 items is a 5-pointLikert-type (5 = agree completely to 1 = disagree completely). Ten items are scored in reverse order. The scores ranged from 33 to 165. SCIB subscales include internal control, external control, and support. The scale has no cutoff score, higher scores are associated with a higher degree of perceived support and of control during birth. The Cronbach's alpha for the original scale was measured as .95 (Ford et al., 2009) and Turkish version was measured as 0.84 (Inci et al.,2015). In this study, this scale was administered within 24 hours postpartum. |
Postpartum 24th hours
|
Birth Trauma (City BITS)
Time Frame: Postpartum 8 th week
|
Birth trauma of women were evaluated with the City Birth Trauma Scale.
City BiTS was developed by Ayers et al., (2018) to measure birth trauma.
The Turkish validity and reliability of the scale were performed by Bayrı Bingöl et al. (2021).
The scale is a fourpoint Likert-type instrument composed of 29 items.
Higher scores reflect greater risk for Post-traumatic Stress Disorder (PTSD).
The Cronbach's alpha for the original scale was measured as .92
(Ayers et al.,2018) and Turkish version was measured as 0.91 (Bayrı Bingöl et al., 2021).
In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.
|
Postpartum 8 th week
|
Maternal Attachment (MAI)
Time Frame: Postpartum 8 th week
|
Maternal attachment of women was evaluated with the Maternal Attachment Inventory. MAI, was developed by Muller (1994) to measure maternal attachment. The Turkish validity and reliability of the scale were performed by Kavlak et al. (2009). This scale consisting of 26 items is a 4-point Likert-type (4 = every time to 1 = any time). The scores ranged from 26 to 104 and high scores indicated higher maternal attachment. The Cronbach's alpha for the original scale was measured as .76 - .85 at different time (Muller, 1994) and Turkish version was measured as 0.77 (Kavlak et al., 2009). In this study, 6th to 8th postnatal days were used to measure maternal attachment. |
Postpartum 8 th week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GIsbir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychological Well-being
-
University of JyvaskylaAcademy of FinlandCompleted
-
Samuel Lunenfeld Research Institute, Mount Sinai...Not yet recruiting
-
Samuel Lunenfeld Research Institute, Mount Sinai...RecruitingWell-Being, PsychologicalCanada
-
University of Wisconsin, MadisonNot yet recruiting
-
Hong Kong Metropolitan UniversityNot yet recruiting
-
Larena SASNot yet recruitingWell-Being, PsychologicalFrance
-
Catholic University of the Sacred HeartCompleted
-
Heidelberg UniversityCompleted
-
Cardiff UniversityNot yet recruiting
-
University of RochesterCenters for Disease Control and PreventionNot yet recruitingWell-Being, PsychologicalUnited States
Clinical Trials on Continouse supportive care
-
Memorial Sloan Kettering Cancer CenterUConn HealthActive, not recruitingAdvanced CancerUnited States
-
Centre Henri BecquerelRecruiting
-
Kaleido BiosciencesCompletedMild-to-Moderate COVID-19United States
-
Kaleido BiosciencesCompletedMild-to-moderate COVID-19United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Completed
-
University of Colorado, DenverNational Institute of Nursing Research (NINR); University of California, San...CompletedParkinson Disease | Alzheimer Disease | Lewy Body Disease | Parkinsonism | Supranuclear Palsy, Progressive | Parkinsonism Vascular | Multiple System Atrophy | Corticobasal Degeneration | Frontotemporal Dementia | Primary Progressive Aphasia | Vascular DementiaUnited States
-
Kaleido BiosciencesCompleted
-
VA Office of Research and DevelopmentCompletedLung CancerUnited States
-
Assistance Publique - Hôpitaux de ParisUnknownIdiopathic Pulmonary FibrosisFrance
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedOvarian Carcinoma | Malignant Uterine Neoplasm | Malignant Female Reproductive System Neoplasm | Ovarian Neoplasm | Uterine Neoplasm | Female Reproductive System Neoplasm | Suspicious for MalignancyUnited States