- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07654881
THE EFFECT OF REIKI APPLIED DURING THE POSTPARTUM PERIOD ON THE QUALITY OF POSTPARTUM RECOVERY, COMFORT AND MOOD.
THE EFFECT OF REIKI APPLIED DURING THE POSTPARTUM PERIOD (AFTER CESAREAN SECTION) ON THE QUALITY OF POSTPARTUM RECOVERY, COMFORT AND MOOD.
The postpartum period, also defined as the fourth trimester of pregnancy, encompasses the approximately 6-8 week period following childbirth, during which the organs that underwent changes during pregnancy return to their previous state. This period is of great importance in terms of protecting the health of both mother and baby, meeting their care needs, and increasing their comfort. During the postpartum period, women experience physiological, psychological, and social changes; hormonal changes, assuming parental roles, changes in family dynamics, and increased responsibilities related to infant care can lead to adjustment difficulties. This can cause problems for the mother in both her own care and infant care.
In the postpartum period, mothers may experience various health problems such as pain, fatigue, sleep disturbances, infections, breastfeeding problems, hemorrhoids, constipation, urinary incontinence, depressive symptoms, and mood swings. Pain, in particular, arises due to uterine contractions, breast engorgement, nipple tenderness, and other complications, negatively affecting the mother's mobility, sleep patterns, social interaction, and quality of life. Furthermore, stress and adjustment problems experienced during the postpartum period can lead to serious psychological problems such as delayed maternal bonding, postpartum blues, postpartum depression, psychosis, and communication problems between couples.
Pharmacological and non-pharmacological methods are used in the management of these problems. However, due to the negative effects that pharmacological methods may have during breastfeeding, interest in complementary and alternative medicine practices has increased. Reflexology, aromatherapy, music therapy, acupressure, and Reiki are among these methods.
Reiki is an energy therapy method that aims to balance an individual's life energy and support the natural healing process, applied through touch or the placement of hands on specific points. Reiki application is reported to have positive effects on pain, stress, anxiety, sleep quality, and coping skills. Although it is one of the preferred methods for adapting to changes and reducing problems experienced in the postpartum period, studies directly examining the effects of Reiki application on postpartum recovery quality, comfort, and mood are quite limited. Due to its low cost, ease of application, and lack of side effects, Reiki is considered an important complementary care approach that can be used in the postpartum period.
The aim of this study is to determine the effect of face-to-face Reiki treatment on the quality of postpartum healing, comfort level, and mood in women who have had cesarean deliveries, on days 1, 2, and 7 of the postpartum period.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Problem Definition and Significance The postpartum period begins with the completion of childbirth and includes the 6-8 weeks during which the organs that changed during pregnancy return to normal. It is also considered the fourth trimester of pregnancy. This period is an important one for the mother, as it focuses on maintaining the health and comfort of the baby. During this period, women experience physiological, psychological, and social changes (Tsai and Wang, 2019; Kılıçlı and Zeyneloglu, 2024). The changes experienced during pregnancy in mothers regress, the reproductive organs enter the involution process, and the lactation process matures. In addition, the postpartum period is a time when the mother's responsibilities increase due to hormonal changes, the acquisition of parenting roles, changes in family dynamics, and issues such as infant care, safety, and nutrition. These changes affect coping skills and can cause the mother to experience problems with her own care and infant care. Also, during this period, the mother; Mothers may experience serious problems such as pain, mobilization, breastfeeding difficulties, fatigue, exhaustion, infection, urinary incontinence, hemorrhoids, constipation, sleep disorders, depressive symptoms, and emotional changes (Rezaei et al., 2016; Martínez-Galiano et al., 2019). When these problems are not managed, the physiological and psychological problems experienced by the mother can negatively affect the health of family members and delay healing (Sines et al., 2007). Another problem that delays healing is pain. However, pain varies depending on uterine contractions, hemorrhoids, breast engorgement, nipple tension, and other complications. Pain experienced during this period can lead to fatigue, mobilization problems, sleep problems, impaired social interaction, and emotional problems (Öztürk et al., 2020). This situation causes fatigue in the mother and reduces her quality of life and comfort (Karaca and Vural, 2022; Uzunkaya Öztoprak et al., 2023). Managing the pain will increase the mother's comfort and positively affect her psychological state. However, although the postpartum period is a time of positive emotions for the mother, it can also trigger a crisis period due to hormonal changes. When the mother cannot adapt to these crisis situations, the stress of the mother and other family members increases. Increased stress levels can lead to serious emotional problems such as delayed maternal bonding, postpartum sadness, postpartum depression, psychosis, and communication breakdowns between couples (Rezaei et al., 2016; Martínez-Galiano et al., 2019). When the literature is examined, pharmacological or non-pharmacological methods can be used to solve these problems. However, the undesirable effects of pharmacological methods during breastfeeding have made non-pharmacological methods an alternative in managing these symptoms. These methods, called complementary and alternative medicine (CAM) practices, are frequently encountered in nursing care literature recently due to their low cost, simplicity, and non-harmful nature. Examples of these practices include reflexology, aromatherapy, music therapy, and acupressure. Reiki, a type of energy therapy, is also among these practices. Reiki is an energy therapy method that aims to balance the life energy in the body and support the healing process, applied through touch or by placing hands on specific points on the body. It aims to contribute to the physiological, social, and psychological well-being of the individual and focuses on the energy chakras. Reiki application, as an energy-based and touch-based relaxation method, aims to support the body's natural healing process and is considered a natural healing energy. Studies have shown that Reiki positively affects pain, stress, anxiety, vital signs, sleep, and coping skills. It is one of the preferred methods in Turkey and worldwide for adapting to changes occurring in the postpartum period, managing crisis situations, and reducing problems that arise during this period. Studies in the literature addressing the effects of Reiki in the postpartum period are quite limited. In particular, there is no study that directly examines the impact of face-to-face Reiki application on the quality of postpartum recovery, comfort, and mood during the postpartum period. The fact that Reiki can be applied without any pharmacological treatment, without side effects, and is both low-cost and easily accessible makes this method extremely valuable, especially during the sensitive postpartum period. Furthermore, the fact that Reiki can be applied in both clinical and home settings increases its potential to respond to the sustainable care needs of the postpartum period.
Purpose of the Study This research aims to investigate the impact of face-to-face Reiki application on the quality of postpartum recovery, comfort, and mood in women who have had cesarean deliveries during the postpartum period (days 1, 2, and 7).and is designed to determine its effect on mood.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Beyhan Şimşek
- Telefonní číslo: +90 539 244 27 19
- E-mail: hembeyhan123@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Ages 19-35
- Literate and able to communicate
- Those who gave birth after 37 weeks of gestation
- Those who had a single or intrauterine delivery
- Those who meet the inclusion criteria and volunteer to participate
- Those residing within the central district of Gaziantep province
- Those who received spinal/epidural anesthesia
Exclusion Criteria:
- Having an infectious skin disease
- Having a chronic illness (diabetes mellitus, hypertension, etc.)
- Having complications related to the birth process
- The baby not being present for any reason
- Using sedative agents for any reason
- Mothers with disabled babies
- Having experienced an acute psychiatric attack
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: routine care
Participants in the control group will receive routine postpartum care provided in the clinic.
This includes standard monitoring of the mother and newborn in accordance with hospital protocols, assessment of maternal postpartum recovery, monitoring of vital signs, and provision of nursing and medical care interventions when necessary.
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Participants in the control group will receive only standard postpartum care and monitoring during the study period.
These participants will be evaluated on days 1, 2, and 7 postpartum at the same time as the experimental group; however, no Reiki intervention will be applied.
Participants will continue to receive routine clinical care services, and all data collection will be carried out under the same conditions as the experimental group.
This approach will allow for the evaluation of whether the observed outcomes are attributable to Reiki intervention.
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Experimentální: Reiki healing / Reiki therapy
Reiki is a complementary and holistic therapy method of Japanese origin, derived from the words "Rei" (universal) and "Ki" (life energy), meaning "universal life energy."
In Reiki practice, the aim is to balance life energy and support the physical, mental, emotional, and spiritual well-being of the individual by gently touching or placing hands on specific areas of the body.
As a non-invasive, low-risk complementary care approach, Reiki is used in various clinical settings to help reduce stress, promote relaxation, and alleviate symptoms such as pain and anxiety.
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Participants in the experimental group will receive Reiki intervention in addition to standard care practices.
Reiki sessions will be performed by a trained and certified Reiki practitioner in a quiet and suitable environment.
Each session will last approximately 35 minutes and will be applied a total of 3 times: on the 1st, 2nd, and 7th days postpartum.
During the intervention, the practitioner will gently touch or place their hands on designated energy points on the participant's body, in accordance with Reiki principles.
The aim of the intervention is to support the physical, psychological, and emotional well-being of the participants and to contribute to reducing stress and symptom burden.
All applications will be conducted according to a standardized protocol.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Postpartum recovery
Časové okno: 1 year
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Postpartum recovery level will be assessed on postpartum days 1, 2, and 7. Postpartum recovery will be evaluated using the Postpartum Recovery Quality Scale and the REEDA Scale.
The Postpartum Recovery Quality Scale is a 11-item, 10-point Likert-type scale measuring physical, psychological, and functional recovery, with higher scores indicating better recovery.
The REEDA Scale assesses wound healing through redness, edema, ecchymosis, discharge, and approximation of wound edges, with scores ranging from 0 to 15; higher scores indicate poorer healing.
The combined use of these instruments will serve as the primary indicator of postpartum recovery outcomes.
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1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Comfort
Časové okno: 1 year
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Maternal comfort will be assessed as a secondary outcome using the Postpartum Comfort Scale (DSKÖ).
The scale was developed by Karakaplan and Yıldız (2010) and is based on Kolcaba's Comfort Theory.
It is a 34-item, 5-point Likert-type scale evaluating physical, psychospiritual, and sociocultural comfort dimensions.
Total scores range from 34 to 170, with higher scores indicating higher comfort levels.
Item scores are averaged to obtain a mean score between 1 and 5.
The scale includes both positively and negatively worded items, with reverse scoring applied to negative items.
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1 year
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Mood
Časové okno: 1 year
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Maternal mood will be assessed using the Brief Mood Introspection Scale (BMIS).
The scale was originally developed by Mayer and Gaschke (1988) and its Turkish validity and reliability study was conducted by Kavcıoğlu (2011).
It is a 16-item, 4-point Likert-type scale measuring positive and negative mood states.
The positive mood subscale includes items such as happy, calm, energetic, and affectionate, while the negative mood subscale includes items such as sad, tired, tense, and irritable.
Each subscale is scored separately, with total scores ranging from 8 to 32; higher scores indicate higher levels of the respective mood state.
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1 year
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Simge ZEYNELOĞLU, University of Gaziantep
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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