Effect of Therapeutic Touch on Labor Pain and Hormone Levels

NCT ID: NCT05179915

Last Updated: 2024-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-08

Study Completion Date

2023-04-01

Brief Summary

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This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.

A randomized sham controlled trial design was used in the study, which was conducted with 50 primiparous pregnant women. While Therapeutic Touch (25) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (25) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale, a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire and the Perception of Birth Scale.

Keywords: Labor Pain,Therapeutic Touch, Childbirth, Hormones

Detailed Description

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Aim: This study was conducted to determine the effect of sacral region-focused therapeutic touch applied during the latent phase of labour on hormone levels, labour comfort, and perception.

Method: This randomised sham controlled experimental trial was conducted with two groups (intervention and control groups) in a state hospital between 08 March 2022 and 01 April 2023. The sample size of the study was calculated using the G\*power 3.1.9.6 programme. As a result of the calculation, twenty-five pregnant women for each group were included in the study. While Therapeutic Touch (TT) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (STT) was applied in the control group. Data were collected using a Personal Information Form, the Visual Analogue Scale (VAS), a Hormone Values Follow-up Form, the Childbirth Comfort Questionnaire (CCQ) and the Perception of Birth Scale (PBS). IBM SPSS V25 programme was used for statistical analysis of the study. The statistical significance was assessed at the level of p\<0.05.

Conditions

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Therapeutic Touch Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized sham controlled trial design was used in the study, which was conducted with 50 primiparous pregnant women. While Therapeutic Touch (25) focused on sacral region was applied in the intervention group, Sham Therapeutic Touch (25) was applied in the control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
In addition to ensuring the blinding of the participants in the study, blinding was also performed during the data collection, hormone values analysis, statistics and reporting stages. Women who agreed to participate in the study were not informed about the group they were assigned to. Since the participants did not know to which group they were assigned, the study was conducted in a single-blind design.

Study Groups

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Experimental Group

The experimental group will be administered 15-minute therapeutic touch focused on sacral region the latent phase and after it finishes, the participating pregnant woman will be asked to rest for 30 minutes.

Group Type EXPERIMENTAL

Therapeutic Touch focused on sacral region

Intervention Type OTHER

In the latent phase of labor, the field energy of the sacral region will be cleared for an average of 15 minutes.

Placebo Group

After the mimic (sham) therapeutic touch focused on sacral region , the pregnant woman will be asked to rest for 30 minutes.

Group Type PLACEBO_COMPARATOR

Therapeutic Touch focused on sacral region

Intervention Type OTHER

In the latent phase of labor, the field energy of the sacral region will be cleared for an average of 15 minutes.

Interventions

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Therapeutic Touch focused on sacral region

In the latent phase of labor, the field energy of the sacral region will be cleared for an average of 15 minutes.

Intervention Type OTHER

Other Intervention Names

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Placebo Touch (Mimic Touch) focused on sacral region

Eligibility Criteria

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Inclusion Criteria

* Being primipara,
* Having a gestational age of 38-42 weeks,
* Planning to have a normal vaginal delivery,
* Having a 3-4 cm dilation in the latent phase,
* Having a single fetus and head presentation,
* Speaking and communicating in Turkish,
* Agreeing to participate in the study,
* Having no high-risk pregnancy.

Exclusion Criteria

* Receiving induction,
* Receiving labor analgesia/anesthesia,
* Having sensitivity or problems with touch,
* Having to leave during the intervention due to some reasons such as medical procedures, etc.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Ebru Gözüyeşil

Associate Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebru Gözüyeşil, PhD. Associate Professor,

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

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Cukurova University

Adana, Sarıcam, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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[email protected]

Identifier Type: -

Identifier Source: org_study_id

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