- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06700473
Effects of Reiki Intervention During Labor on Pain, Fear, and Birth Experience
Effects of Reiki Intervention During Labor on Pain, Fear, and Birth Experience in Primiparous Women: A Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zeytinburnu
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Istanbul, Zeytinburnu, Turkey, 34020
- İstanbul Eğitim Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Between the ages of 18 and 35, primiparous, singular primarily experiencing pregnancy, without risky pregnancy status (GDM, HT, etc.), during the birth week, literate Speaks and understands Turkish, 4 cm cervical dilatation
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Exclusion Criteria:
To have attended a childbirth preparation course, Knowledge of coping with labor pain and fear of childbirth during pregnancy, Presence of chronic disease in the mother, Previous uterine surgery, Having become pregnant through assisted reproductive technologies, Hearing problems Being diagnosed with a known serious psychiatric illness.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Reiki
Before the intervention, when their cervical dilatation is 4-5 cm, EC-1, EC-2 and EC-3 will be applied to pregnant women in all groups.
After the initial data collection, the researcher TC will apply reiki for approximately 15-20 minutes to pregnant women in the reiki group with cervical dilatation of 4-5 cm.
Immediately after the first intervention, the second EC-2 and EC-3 measurements will be performed.
The third EC-2 and EC-3 measurements will be performed when the cervical dilatation is 6-7 cm and then the fourth EC-2 and EC-3 measurements will be performed after 15 minutes of reiki application.
The fifth EC-2 and EC-3 measurements will be performed when the cervical dilatation is 8-9 cm, followed by 15 minutes of reiki and the sixth EC-2 and EC-3 measurements.
The final data will be collected one hour after delivery of the placenta with the seventh VAS measurement and EK-4.
The EC-4 will also be re-evaluated by the researchers online at the sixth postpartum week.
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Before the intervention, when their cervical dilatation is 4-5 cm, EC-1, EC-2 and EC-3 will be applied to pregnant women in all groups.
After the initial data collection, the researcher TC will apply reiki for approximately 15-20 minutes to pregnant women in the reiki group with cervical dilatation of 4-5 cm.
Immediately after the first intervention, the second EC-2 and EC-3 measurements will be performed.
The third EC-2 and EC-3 measurements will be performed when the cervical dilatation is 6-7 cm and then the fourth EC-2 and EC-3 measurements will be performed after 15 minutes of reiki application.
The fifth EC-2 and EC-3 measurements will be performed when the cervical dilatation is 8-9 cm, followed by 15 minutes of reiki and the sixth EC-2 and EC-3 measurements.
The final data will be collected one hour after delivery of the placenta with a seventh VAS measurement and administration of the EC-4.
The EC-4 will also be reassessed by the researchers online at six weeks postpartum
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No Intervention: Control
Pregnant women in the control group will receive routine midwifery care during labor.
Both groups will not receive any non-pharmacologic intervention for pain management.
All women will receive one-to-one support from midwives during labor.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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labour pain
Time Frame: 5 hours
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reduction of labor pain Visual Analog Scale (VAS) (Annex-2): Visual Analog Scale (VAS) is a scale developed by Price et al. in 1983 and used to measure pain intensity and for pain monitoring.
The VAS is 10 cm long and the two ends are named differently.
On the scale, '0' indicates no pain and '10' indicates the most severe level of pain.
VAS is a measurement tool that is frequently and reliably used to assess labor pain (Price et al., 1983; Mutlu & Özkaya, 2021).
VAS measurement data will be used to test hypothesis H1.
After the primiparous pregnant women included in the study were assigned to the reiki intervention and control groups, the scale will be applied to measure the pretest data when the cervical opening was 4-5 cm before any intervention was applied and to ensure pain equivalence in the groups.
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5 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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labour fear
Time Frame: 5 hours
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reducing the fear of childbirth Birth Fear Scale (ANNEX-3): The scale was developed by Wijma (2002), and its Turkish validity and reliability was conducted by Serçekuş et al.
This scale is designed to assess fear during labor and consists of 10 items.
The administration time varies between 30-90 seconds.
Participants are asked to give each item a score between 1 (completely disagree) and 10 (completely agree).
The minimum score is 10 and the maximum score is 100; a high score indicates a high level of fear.
It is very practical to administer.
The scale consists of 5 positive (1, 3, 5, 7, 10) and 5 negative (2, 4, 6, 8, 9) items.
Positive items are reverse scored.
After the primiparous pregnant women included in the study were assigned to the reiki treatment and control groups, EK-2 will be applied during the birth process follow-up.
The scale will not be applied in the 1st hour after delivery.
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5 hours
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birth memory
Time Frame: 5 hours
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creating positive birth memory Birth memory and recall scale (BMRS) (ANNEX-4): Developed in 2014 by Foley et al. "Birth Memory and Recall Scale," In 2021, it was adapted into Turkish by Topkara and Çağan.
The 7-point Likert-type scale consists of 21 items in total and has six different dimensions: "Emotional Memory," 'Ambivalent Emotional Memory,' 'Centrality of Memory,' 'Consistency and Reliving,' 'Sensory Memory' and "Involuntary Recall."
The highest score that can be obtained from the scale is 147 and the lowest score is 6.
High scores on the Emotional Memory subscale indicate that the mother has more intense negative feelings about the birth experience, while high scores on the Ambivalent Emotional Memory subscale indicate that the mother has more complex and contradictory feelings about the birth experience.
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5 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Uncu, Istanbul University - Cerrahpasa
- Principal Investigator: Comert, Istanbul University - Cerrahpasa
Publications and helpful links
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Individual Participant Data Set
Information identifier: 10.1097/JNR.0000000000000129.Information comments: https://pubmed.ncbi.nlm.nih.gov/28277391/
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.
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