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LabourNCT06700473

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

A study testing reiki in people with Labour, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labour
What is being tested?
reiki
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Nov 2024to 2 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • -

Who cannot join

  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • İstanbul Eğitim Araştırma Hastanesi

    Istanbul, Zeytinburnu, 34020

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Conditions
Labour
Being tested
reiki
Keywords
Reiki, Labour Pain, Delivery, Birth Experience, Fear
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06700473
Study groupRoleWhat they receive
ReikiExperimentalBefore 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.
Receives: Other: reiki
ControlNo interventionPregnant 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 hours

Secondary outcomes (2)

  1. labour fear

    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.

    Measured: 5 hours

  2. birth memory

    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.

    Measured: 5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start2 Nov 2024
  3. Primary completion2 Apr 2025 (estimated)
  4. Study completion2 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-Blind Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06700473
Sponsor's protocol ID
2024/303
Status last verified
Nov 2024
First submitted
20 Nov 2024
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28277391

Questions about this trial

What is this clinical trial studying?

A study testing reiki in people with Labour, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

labour pain (time frame: 5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06700473, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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