NCT05486624

Brief Summary

Purpose: To investigate the effect of Reiki application on postpartum episiotomy recovery and perineal pain in postpartum women who had vaginal delivery. Design and framework: The research is randomized controlled in a pre-test post-test order in a hospital in Turkey. By using Simple Random Numbers Table as the randomization method in the selection of the sample, a total of 86 puerperal women, 40 in the intervention group and 46 in the control group, were recruited. Episiotomy recovery of the intervention and control groups on the 1st day, 2nd day, 7th day, and 14th day postpartum was evaluated with the REEDA Scale, and perineal pain was evaluated with the McGill Pain Scale Short Form. Participants: Postpartum women who gave vaginal birth participated in the study. Intervention: 3 sessions of Reiki for 35-40 minutes were applied to the intervention group on the 1st, 2nd and 7th days of birth. Results: There was a significant difference between the mean REEDA Scale edema scores in the 7th day (p=0.028) and 14th day (p=0.013) follow-up of the intervention and control groups. A significant difference was found between the 3rd post-test McGill Pain Scale Short Form total pain score averages (p=0.005) and the 4th follow-up McGill Pain Scale Short Form total pain score averages (p=0.001) of the intervention and control groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

June 30, 2022

Last Update Submit

August 2, 2022

Conditions

Keywords

Reikiepisiotomyperineal painpuerparant

Outcome Measures

Primary Outcomes (5)

  • Sample power calculation

    It is aimed to determine the number that will represent the universe by calculating the sample power in the study.

    Before starting the research, power analysis was calculated.

  • Introductory Information Form

    In data collection, an Introductory Information Form consisting of 32 questions was used, which included information on socio-demographic characteristics, factors affecting wound healing, obstetric characteristics and hygiene characteristics of puerperant women.

    14 day

  • REEDA Scale

    The REEDA Scale was used by Davidson in 1974. The Turkish validity and reliability study was carried out using the specialty thesis on "The Effect of Hot and Cold Applications on Episiotomy Healing". The scale includes five factors that indicate perineal healing: redness, edema, ecchymosis, discharge, and approaching wound edges. Each improvement factor is evaluated by giving 0, 1, 2 and 3 points. The sum of the scores obtained as a result of the evaluation of five categories constitutes the REEDA score. The lowest score on the scale is 0, and the highest score is 15. The highest score on the scale indicates severe perineal trauma.

    14 day

  • McGill Pain Scale Short Form (MAS-SF)

    MAI-SF, developed by Melzack (1987), provides information about the sensory characteristics of pain, the severity of pain and the effect of pain. The Turkish validity and reliability of the MAI-SF has three parts. In the first part; There are 15 descriptive word groups and expressions containing the characteristics of pain. Descriptive words in this section are rated on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = excessive). In the first part; A total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. The sensory pain score is between 0-33 points, the perceptual pain score is between 0-12 points, and the total pain score is between 0-45 points. An increase in the score indicates an increase in pain. In the second part; There are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of pain. in the third part; Pain intensity is assessed using a 0-10 visual comparison scale.

    14 day

  • Tracking Form

    It is a form in which the 14-day follow-up of postpartum women is made. The status of using analgesics in the form, if he has taken analgesic drug, how many he has taken, how much time has passed between analgesic drugs, analgesic drug name-dose, breastfeeding status of the baby, breastfeeding frequency if he is breastfeeding, giving water/additional nutrition to his baby, and any other factors other than water in episiotomy care. There is information questioning the application status. It was given to the intervention and control groups at the first follow-up and was withdrawn at the fourth follow-up.

    14 day

Study Arms (2)

Control group

NO INTERVENTION

Introductory Information Form was used in the control group on the 1st day of birth with face-to-face interviews. REEDA Scale, MAI-SF were used on the 1st, 2nd, 7th and 14th days of delivery. On the 1st day of birth, the Episiotomy Care Education Brochure and the Follow-up Form to be filled in within 14 days and to be obtained from them at the last follow-up were given. control group; It was evaluated by making a home visit on the 1st day and the 2nd day in the hospital, and on the 7th and 14th days. The records of the forms were filled by the researcher. Data collection time took approximately 15 minutes for the control group. Reiki was not applied to this group.

Intervention group

EXPERIMENTAL

Introductory Information Form was used in the intervention group on the 1st day of birth with face-to-face interviews. REEDA Scale, MAI-SF were used on the 1st, 2nd, 7th and 14th days of delivery. On the 1st day of birth, the Episiotomy Care Education Brochure and the Follow-up Form to be filled in within 14 days and to be obtained from them at the last follow-up were given. intervention group; It was evaluated by making a home visit on the 1st day and the 2nd day in the hospital, and on the 7th and 14th days. Reiki was applied on the 1st, 2nd and 7th days of birth. In total, 3 sessions of Reiki were applied. The records of the forms were filled by the researcher. Data collection took approximately 50-55 minutes for the intervention group.

Other: Reiki

Interventions

ReikiOTHER

Reiki, one of the complementary treatments, was applied by touching the chakra areas of the body by hand.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and over,
  • No risky pregnancy (no systemic disease, no smoking, no postpartum complications),
  • The gestational week is 37-42 weeks,
  • Single and live vaginal delivery,
  • Mediolateral episiotomy performed,
  • No vaginal infection,
  • Not using any medication,
  • No laceration (anal sphincter injury, 3rd degree perineal laceration) other than episiotomy,
  • Only puerperant women who use clean water for perineum care and keep them dry will be included in the study.

You may not qualify if:

  • Under 18 years old,
  • Having a risky pregnancy,
  • Gestational week other than 37-42 weeks,
  • Having multiple births, stillbirths and anomalies,
  • Having episiotomy other than mediolateral episiotomy,
  • Having vaginal infection,
  • Using any medication,
  • Having laceration other than episiotomy,
  • Cesarean section,
  • Does not meet the standard of using clean water and keeping it dry in perineum care (doing different care or using pharmacological products),
  • Postpartum women who do not accept home visits will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Training and Research Hospital

Kırşehir, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Therapeutic Touch

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • NERİMAN S

    neriman.sogukpinar@ege.edu.tr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 1 control group, 1 intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Health Sciences / Midwifery Department / Assistant Professor Doctor

Study Record Dates

First Submitted

June 30, 2022

First Posted

August 3, 2022

Study Start

August 1, 2020

Primary Completion

September 30, 2020

Study Completion

June 30, 2021

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations