NCT06700473

Brief Summary

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.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 2, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 20, 2024

Last Update Submit

November 22, 2024

Conditions

Keywords

Reiki, Labour Pain, Delivery, Birth Experience, Fear

Outcome Measures

Primary Outcomes (1)

  • labour pain

    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 Outcomes (2)

  • labour fear

    5 hours

  • birth memory

    5 hours

Study Arms (2)

Reiki

EXPERIMENTAL

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.

Other: reiki

Control

NO INTERVENTION

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.

Interventions

reikiOTHER

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

Reiki

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen as labor will take place
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Eğitim Araştırma Hastanesi

Istanbul, Zeytinburnu, 34020, Turkey (Türkiye)

Location

Related Publications (1)

  • Isbir GG, Sercekus P. The Effects of Intrapartum Supportive Care on Fear of Delivery and Labor Outcomes: A Single-Blind Randomized Controlled Trial. J Nurs Res. 2017 Apr;25(2):112-119. doi: 10.1097/JNR.0000000000000129.

    PMID: 28277391BACKGROUND

Related Links

MeSH Terms

Conditions

Labor Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Uncu

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Comert

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
After being randomized as experimental and control groups, primiparous pregnant women will be prevented from interacting with each other in order not to be affected by the interventions.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-Blind Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

November 2, 2024

Primary Completion

April 2, 2025

Study Completion

May 2, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Individual Participant Data Set (10.1097/JNR.0000000000000129.)Access

Locations