NCT06364436

Brief Summary

This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

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

June 3, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.8 years

First QC Date

April 4, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

Postpartum periodNursingDistant ReikiPostpartum depressionFatigue

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale for Fatigue (VAS-F)

    Lee et al. (1990) and whose Turkish validity and reliability were determined by Yurtsever and Bedük (2003), the scale consists of 18 items. The scale is in the form of a 10 cm ruler with the most positive statements at one end and the most negative statements at the other end. The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10. The most negative expression of the energy sub-dimension is 0 and the most positive expression is 10. The items of the fatigue sub-dimension are from the most positive to the most negative, and the items of the energy sub-dimension are from the most negative to the most positive. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue is high. Evaluation of the scale is done by adding the total scores (0-180) obtained from the items. The scale does not have a cut-off point.

    two months

  • Edinburgh Postnatal Depression Scale (EPDS)

    he scale prepared for screening purposes to determine the risk of depression in the postpartum period was developed by Cox et al. (1987), the scale is not intended to diagnose depression. EPDS consists of 10 items and is a 4-point Likert type. The answers to each question item are scored between 0-3 on a scale consisting of four options, the lowest score that can be obtained from the scale is 0 and the highest score is 30. In the evaluation, the 1st, 2nd, and 4th items are scored as 0, 1, 2, 3, and the 3rd, 5th, 6th, 7th, 8th, 9th, and 10th items are scored reversely as 3, 2, 1. is scored as 0. The total score of the scale is obtained by adding these item scores. The cut-off score of the scale is 12.5 and women whose total scale score is higher than the cut-off point are considered to be in the risk group. Turkish validity and reliability were determined by Aydin et al. (2004) Cronbach Alpha coefficient of the scale was found to be 0.76.

    two months

Study Arms (2)

Reiki Energy therapy

EXPERIMENTAL

The women in the intervention group were explained how to perform the Reiki application, and the appropriate time for Reiki was planned. Pretest data were obtained by sending the data collection form, VAS-F and EPDS Google form link to women's phones via WhatsApp application.Then, according to Usui Reiki, researchers with Reiki Stage II and Reiki Master \& Teacher degrees applied Reiki to women for 30 minutes consecutively on the 13th, 14th, 20th and 21st postpartum days (in the second and third postpartum weeks). Before each Reiki application, a reminder message was sent to the women informing them that the application would begin, and they were asked to fill out the VAS-F and EPDS again on the 28th day (fourth week) and 56th day (eighth week) postpartum. During this process, women who did not fill out the scale forms were contacted via phone and SMS and were asked to fill out the forms, and those who did not fill out the forms were excluded from the study.

Behavioral: Reiki energy therapy

Control

NO INTERVENTION

No intervention was made to the women in the control group during the research. Women in the control group were asked to fill out the introductory information form and VAS-F and EPDS on the 13th postpartum day, and the VAS-F and EPDS form links were sent to their phones via WhatsApp on the 28th and 56th days.

Interventions

In order to perform distance Reiki application, the practitioner must have completed Reiki II level training according to the Traditional Usui Reiki system and must be attuned by a person with a Usui Reiki Master and Teacher degree. With harmony, the energy channels in the individual's body are opened and the harmonious individual becomes a tool of universal healing energy.

Reiki Energy therapy

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants were 18 years of age or older
  • At least a primary school graduate
  • Primiparous and multiparous, with a full-term (between 38-40 weeks) and healthy newborn
  • Without any acute or chronic health problems, without communication problems that could answer the data collection tools used in the study
  • Women who had not received body-mind therapy (yoga, reiki, meditation, etc.) in the last six months
  • Women who agreed to participate to the research

You may not qualify if:

  • Women who could not be contacted for the pre-test application on the 13th postpartum day
  • Women who developed a health problem in themselves or/or their newborn
  • Women who were diagnosed with a neuro-psychiatric disease
  • Women who could not be reached by phone or SMS on the 13th and 14th postpartum days
  • Women who wanted to leave the study voluntarily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, PostpartumFatigue

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ILKNUR GOKSIN, PhD

    Aksaray University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 15, 2024

Study Start

June 3, 2022

Primary Completion

March 18, 2024

Study Completion

June 26, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations