Effect of Therapeutic Touch on Labor Pain and Hormone Levels

Study Overview
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Brief Summary
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Levels of pain and anxiety experienced during labor are important factors affecting maternal and infant health. One indicator affecting these factors is labor-specific hormone levels in the uterus. Therapeutic touch practice is a CAT (Complementary and Alternative Therapies) method, and its effect on these factors will be a guide for future practice. The study participants will be women who are accepted to the delivery room of Adana Seyhan Public Hospital affiliated to Adana City Health Administrative of T.R. Ministry of Health between 01th of January 2022 and 01th of January 2023. The sample size of the study was calculated using G*power 3.1.9.6 program. Data obtained from the study conducted by Türkmen and Tuna Orhan (2021) were utilized for the effect size to be used for the calculation of the sample size. With d=0.86 effect size, 5% margin of error (α=0.05), 80% power (1-β=0.80), the sample size was calculated as 23 for the experimental group and 23 for the control group. Considering potential losses in the process, the sample size in both groups was increased by 10% and 25 pregnant women in each group were decided to be included in the study. An average of 15-minute therapeutic touch will be administered in the experimental group. As for the control group, they will be administered fake therapeutic touch for 15 minutes. Data will be collected using the pre and post-therapeutic touch hormone levels, Visual Analogue Scale (VAS), the Childbirth Comfort Scale (CCS), and spit sample. Maternal Perception of Labor Scale (MPLS) data will be collected after the administration is finished. Data will be analyzed using Social Sciences Statistical Package Program 20.0. Very few studies have been conducted on whether labor pain can be decreased effectively using therapeutic touch. However, there are no placebo-controlled and single-blind experimental studies that investigated the effect of therapeutic touch practice during labor on labor pain, labor perception, childbirth comfort, endorphin, oxytocin, and cortisol hormone levels. Therefore, this study will be conducted as a randomized-controlled study to investigate the effect of therapeutic touch on labor pain, labor perception, childbirth comfort, endorphin, oxytocin, and cortisol hormone levels.

Official Title
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Effect of Therapeutic Touch on Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort

Conditions
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Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort

Intervention / Treatment
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* Other: Therapeutic Touch


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The experimental group will be administered 15-minute therapeutic touch in the latent phase and after it finishes, the participating pregnant woman will be asked to rest for 30 minutes. | Other: Therapeutic Touch<br>* In the latent phase of labor, the field energy of the sacral region will be cleared for an average of 15 minutes.<br>* Other names: Placebo Touch (Mimic Touch);|
| Placebo Comparator: Placebo Group<br>After the mimic (sham) therapeutic touch finishes, the pregnant woman will be asked to rest for 30 minutes. | Other: Therapeutic Touch<br>* In the latent phase of labor, the field energy of the sacral region will be cleared for an average of 15 minutes.<br>* Other names: Placebo Touch (Mimic Touch);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | VAS is a one-dimensional scale that objectively assesses pregnant woman's perception of pain. VAS is a 100 mm scale (10-cm) that represents lack of pain (0=no pain) on one end and worst possible pain (10=severe pain) on the other end; the scale is used to determine the severity of pain quantitatively. The patient marks any point between the two ends that describe his/her pain severity. The point between lack of pain and the point indicated by the patient is measured using a ruler and recorded as cm. These numeric values indicate the pregnant woman's pain severity. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Perception of Labor Scale (MPLS) | MPLS is a measurement tool that assesses how mothers perceive their experiences in normal delivery or planned cesarean sections. The sub-scales of the scale include experiences during labor (7 items: 3, 5, 6, 8, 15, 17, 18), experiences during the pain phase of labor (7 items; 1, 2, 4, 7, 9, 10, 16), end of labor (4 items: 22, 23, 24, 25), partner involvement (4 items; 11,12,20,21), and awareness (3 items; 13,14,19). Each item in the MPLS is rated between 1 and 5: 1-Never, 2-A little, 3-Moderate, 4-A lot, and 5-Too much. Since Items 15-16-17-18-19 in the scale include negative statements, these items are scored reversely. Cronbach's alpha value of the scale was 0.90, and the alpha values obtained using two half-test methods were found 0.83 and 0.81. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor Pain, Therapeutic Touch, The level of hormones, Childbirth