Effect of Therapeutic Touch on Labor Pain and Hormone Levels

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 Trialt

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

Study Overview

• Status: Completed
• Conditions: Therapeutic Touch; Childbirth
• Intervention / Treatment: Other: Therapeutic Touch focused on sacral region

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sarıcam
    • Adana, Sarıcam, Turkey, 01330
      • Cukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: Placebo Touch (Mimic Touch) focused on sacral region
Placebo Comparator: Placebo Group; After the mimic (sham) therapeutic touch focused on sacral region , the pregnant woman will be asked to rest for 30 minutes.	Other: 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.; Other Names: Placebo Touch (Mimic Touch) focused on sacral region

What is the study measuring?

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.	VAS were evaluated after application 30 minutes in each groups.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Perception of Birth Scale (PBS)	MPLS PBS,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.	PBS were evaluated after delivery in each groups.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Childbirth Comfort Questionnaire (CCQ)	The original name of the scale was the "Childbirth Comfort Questionnaire", and it was developed by Kerri Durnell Schuiling in 2003 based on Kolcaba's comfort theory (7). Turkish reliability and validity of the Childbirth Comfort Questionnaire were performed by Potur et al. (2015) (8). Cronbach's alpha coefficient of the scale was found 0.75. The 14-item scale is rated on a 5-point scale. Each item is responded considering the comfort in the delivery room. Each item in the original scale is reported to be scored between 1 and 5 (1=I strongly disagree, 2= I disagree, 3=I partly agree, 4= I agree, 5=I strongly agree). Scores to be obtained from the scale range between 14 and 70. Before the total score is calculated, item 2,4,6,9,12,13,14 should be reversed. While higher scores indicate a high level of comfort, lower scores indicate a low level of comfort.	CCQ were evaluated after application 30 minutes in each groups.
Hormones	Samples took from pregnant women two times for oxytocin, endorphin, and cortisol analyses, which will include right before starting Therapeutic Touch (TT) in the latent phase of the first phase of labor and 30 minutes after the therapeutic touch. The samples will be collected in 1.5 ml Eppendorf tubes that will have 70 μL spit sample. The samples will be taken to deep freezers at the Genetic Department of Medical Faculty at Çukurova University following the cold-chain rule and waited at -80 °C until the analysis day	a maternal saliva sample for hormones was took pretest and posttest (after application in 30 minutes).

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Ebru Gözüyeşil, PhD. Associate Professor,, Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Childbirth; Hormones; Therapeutic Touch; Labor Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: egozuyesil@cu.edu.tr

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No