- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447609
THE EFFECT OF REIKI ON BREASTFEEDING, PAIN AND COMFORT AFTER CESAREAN SECTION
THE EFFECT OF REIKI APPLIED DURING THE POSTPARTUM PERIOD ON BREASTFEEDING, PAIN, AND COMFORT IN WOMEN WHO DELIVERED BY CESAREAN SECTION
EFFECT OF REİKİ APPLİED DURİNG THE POSTPARTUM PERİOD ON BREASTFEEDİNG, PAİN, AND COMFORT IN WOMEN WHO DELİVERED BY CESAREAN SECTİON
The aim of this randomized controlled trial is to determine the effect of Reiki applied to volunteer women after cesarean section on breastfeeding, pain, and comfort in the postpartum period. The main questions it aims to answer are:
Is there a difference in postpartum breastfeeding, pain, and comfort between the group receiving Reiki and the group receiving standard care? Is there a difference in postpartum breastfeeding, pain, and comfort between the group receiving Reiki and the group receiving Sham Reiki? Participants will receive Reiki six times postpartum: three times one-on-one during their hospital stay, and remotely in the second, third, and fourth weeks. The control group will receive standard care. The Sham Reiki group will receive Reiki points applied by a person without Reiki knowledge.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be one of the rare studies that holistically evaluates the effects of Reiki application on pain, breastfeeding success, self-efficacy, comfort, and perception of milk supply in the postpartum period. Scales will be evaluated before and after Reiki sessions, and both the physiological and psychosocial healing process will be examined holistically.
The increase in cesarean section rates is associated with pain, mobility limitations, and increased care needs during hospital stay in the postpartum period. Postpartum pain and functional limitations due to the postoperative healing process can negatively affect early breastfeeding initiation, correct latching, and mother-infant interaction, thus reducing breastfeeding success (Buchko et al., 2022; Chang et al., 2021). Postpartum pain can delay or weaken breastfeeding adaptation; Therefore, the gains from comfort-enhancing interventions for mothers who have undergone cesarean delivery are important in terms of breastfeeding outcomes.
Complementary and supportive care approaches, especially non-pharmacological methods, can increase the effectiveness of nursing care by reducing maternal comfort and anxiety in the postpartum period (Lee & Frazier, 2019). Energy-based practices such as Reiki are included in the literature with studies reporting positive effects on postoperative pain, anxiety, and some physiological parameters (Midilli & Eser, 2015; Thrane & Cohen, 2014). However, some randomized controlled trials have not found a significant difference (van der Vaart et al., 2011). This situation necessitates the evaluation of the effect of Reiki on breastfeeding and comfort in the post-cesarean period with well-designed, repeated-measurement randomized controlled trials. This study aims to examine the short-term (before/after each session) and mid-term (before and after discharge) effects of Reiki administered face-to-face in six short periods postoperatively at 0-4, 6-12, and approximately 24 hours, and remotely at 2, 3, and 4 weeks postpartum, using multiple scales. The literature shows that the LATCH (Jensen et al., 1994) and BSES-SF (Dennis, 2003) scales are used to predict breastfeeding performance and self-efficacy in the early postpartum period; perceived insufficient milk is closely related to weaning (Huang et al., 2021); and postpartum comfort can vary with delivery type or support interventions (Kolcaba, 2003). Therefore, the combined use of these scales strengthens the clinical and nursing care implications of this study.The research design is a randomized controlled, single-blind study.
- Blinding: Participants can be blinded; however, due to the nature of Reiki, the practitioner cannot be blinded. Since the researcher and practitioner are the same person, the Reiki group is known through pre- and post-session assessments. Participants selected for the study will be assigned to a group by coin toss upon admission. Participants will not be informed of their group assignment during the treatment.
- This is a single-center study, and participants will be selected from women who have given birth at the Obstetrics and Gynecology Department of Samsun Training and Research Hospital, and who meet the inclusion criteria.
Inclusion/Exclusion Criteria Participants will be 18-45 years old, have had a single live birth, a planned/emergency cesarean section, be hemodynamically stable, have no problems with breastfeeding in the first 24 hours postoperatively, and be fluent in Turkish. Individuals with preeclampsia/eclampsia, active postpartum hemorrhage, sepsis/fever ≥38°C, need for intensive care, delivery before 37 weeks, serious neonatal problems, separation of mother and baby after birth (follow-up in neonatal intensive care unit without hospitalization), excessive sedation due to analgesia, communication difficulties, and a markedly negative attitude towards Reiki will be excluded from the study.
Timing and Measurements
Application Times (6 sessions):
- 0-4 hours postpartum day 0
- 6-12 hours postpartum day 0
- 24 hours and on postpartum day 1
- Remote Reiki in the 2nd week postpartum
- Remote Reiki in the 3rd week postpartum
- Remote Reiki in the 4th week postpartum
Before the first Reiki session:
- Vital signs: Fever, Pulse, Blood Pressure, SpO₂
- VAS (0-10)
- LATCH
- BSES-SF (Breastfeeding Self-Efficacy Short Form) (pre-test)
- Perceived Insufficient Milk Questionnaire (pre-test)
- Postpartum Comfort Questionnaire (PSQI) (pre-test) Before each face-to-face Reiki session: • Vital signs
- VAS
- LATCH
After each face-to-face Reiki session:
- Vital signs
- VAS
- LATCH
- Reiki experience form
Before discharge (usually 24-72 hours):
- BSES-SF (Short Form of Breastfeeding Self-Efficacy)
- Perceived Insufficient Milk Questionnaire
- Postpartum Comfort Questionnaire (PMCQ)
Post-Discharge Follow-up:
Participants in the Reiki and Sham Reiki groups will be informed by phone before the Reiki session in the second and third weeks, and a phone call will be made after the session for feedback. In the fourth week, a phone call will be made to inquire about the baby's exclusive breastfeeding status (yes/no), the need for formula feeding (yes/no), breastfeeding frequency (how many times a day the baby breastfeeds), the baby's weight gain, and insufficient milk. The perception scale, breastfeeding self-efficacy scale, and postpartum comfort scale will be evaluated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gozde G Cakmak, specialist nurse, phd student
- Phone Number: +905553603460
- Email: gzdnzm@gmail.com
Study Locations
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Samsun, Turkey (Türkiye)
- Recruiting
- Samsun Sehir Hastanesi
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Contact:
- Gözde Gülfiye Çakmak
- Phone Number: 05553603460
- Email: gzdnzm@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mothers aged 18 and over,
- Literate in Turkish,
- Non-smoker, non-drug user,
- Gave birth by cesarean section at term,
- Baby with them after birth,
- Not using any breast milk-increasing medication, vitamins, or supplements,
- Baby's birth weight between 2500-4000 grams,
- Baby's Apgar score at least seven points at 1 and 5 minutes,
- Having had a cesarean section under spinal anesthesia,
- Those who agree to participate in the study.
Exclusion Criteria:
- Preeclampsia/eclampsia, active postpartum hemorrhage, sepsis/fever ≥38°C,
- Need for intensive care,
- Birth before 37 weeks,
- Serious neonatal problems,
- Baby arriving at the ward after mother (follow-up in neonatal intensive care unit without hospitalization after birth),
- Excessive sedation due to analgesia,
- Communication difficulties,
- Markedly negative attitude towards Reiki.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: reiki therapy
Intervention (Reiki Procedure)
In distance Reiki practice, the Reiki practitioner will send Reiki to the participant by visualizing them using their Level 2 Reiki knowledge. |
The effect of Reiki practice on breastfeeding during the postpartum period has not been evaluated; it is considered unique because it is evaluated together with its effect on pain and comfort, and offers a holistic approach to support care for women in the postpartum period.
Other Names:
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Placebo Comparator: sham reiki
Reiki is a complementary therapy that originated in Japan and is increasingly offered in mainstream healthcare. It involves a trained practitioner gently placing their hands on or just above the recipient's body to activate the energy in the existing biological field within the body, restoring "energetic balance" and supporting the body's natural healing processes. Sham reiki, on the other hand, is a practice that mimics reiki but is performed by a healthcare professional who does not have a reiki certification. Intervention Procedure
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It is believed that adding a sham reiki group alongside postpartum reiki treatment will increase the reliability and originality of the study.
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No Intervention: control group
Routine postpartum care • Measurements at the same time points:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In women who have had a cesarean section, Reiki applied at six separate times during the postpartum period affects their self-efficacy in breastfeeding.
Time Frame: Women who have had a cesarean section will be assessed using a breastfeeding self-efficacy scale through face-to-face meetings on the first and second postoperative days, and by telephone during the fourth week.
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Postpartum Reiki therapy has not been used to study breastfeeding self-efficacy in women who have had cesarean sections. The literature includes studies where Reiki therapy was applied to third-trimester pregnant women and breastfeeding self-efficacy was evaluated. Breastfeeding self-efficacy has been assessed after both cesarean and vaginal deliveries, but there are no studies using Reiki as an intervention. In this sense, the effect of Reiki on breastfeeding parameters is intriguing. Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). The Breastfeeding Self-Efficacy Scale, originally developed by Dennis and Faux in 1999, is a 33-item scale designed to assess breastfeeding self-efficacy levels. Following internal consistency testing, items with item-total correlations below 0.60 were removed, resulting in a shortened form of the new 14-item Breastfeeding Self-Efficacy Scale. The Cronbach's alpha reliability coefficient of |
Women who have had a cesarean section will be assessed using a breastfeeding self-efficacy scale through face-to-face meetings on the first and second postoperative days, and by telephone during the fourth week.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Gulten Guvenc, prof. dr., sağlık bilimleri university Faculty of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK 2025/24/20
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
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