Effects of Reiki Intervention During Labor on Pain, Fear, and Birth Experience

November 22, 2024 updated by: Ozlem TAS, Istanbul University - Cerrahpasa

Effects of Reiki Intervention During Labor on Pain, Fear, and Birth Experience in Primiparous Women: A Randomized Controlled Trial

Childbirth is an important and often stressful experience for many women, and labor pain is common among women. While labor pain is a natural part of the birth process, its severity and management can have a significant impact on an expectant mother's overall health and birth experience. Studies examining the effects of Reiki on alleviating the pain and fear experienced by pregnant women during labor are limited. In this context, understanding the effects of Reiki practices in the birth process may be important for both clinical practice and future research.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Failure to control pain can cause the mother to experience fear and stress, which can increase the risk of complications during labor and indirectly have negative effects on the newborn. There is a strong association between labor pain and fear. Fear can increase the perception and intensity of pain, making the labor process more challenging and difficult to manage. This can negatively affect the mother's overall birth experience and complicate both the physical and emotional aspects of the birth process. A woman's birth experience also has an impact on her birth memory. A positive birth experience can cause a woman to evaluate the birth process as peaceful and satisfying, which positively shapes birth memory. The use of complementary and alternative therapies is increasing every year. Although Reiki has found application in various fields, there is no information in the available literature on its use in the management of labor pain. Reiki is a complementary treatment method based on the "energy approach" and is generally recognized as safe and without side effects.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey, 34020
        • İstanbul Eğitim Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

-

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
labour pain
Time Frame: 5 hours
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.
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
labour fear
Time Frame: 5 hours
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.
5 hours
birth memory
Time Frame: 5 hours
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.
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Uncu, Istanbul University - Cerrahpasa
  • Principal Investigator: Comert, Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2024

Primary Completion (Estimated)

April 2, 2025

Study Completion (Estimated)

May 2, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

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)?

NO

Study Data/Documents

  1. 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

No

Studies a U.S. FDA-regulated device product

No

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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