Effect of Therapeutic Touch on Labor Pain and Hormone Levels

NCT05179915 | Completed DMC

• 1 other identifier: egozuyesil@cu.edu.tr
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Therapeutic Touch; Childbirth

Keywords

Labor Pain; Therapeutic Touch; Childbirth; Hormones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Perception of Birth Scale (PBS)

  PBS were evaluated after delivery in each groups.

Other Outcomes (2)

• The Childbirth Comfort Questionnaire (CCQ)

  CCQ were evaluated after application 30 minutes in each groups.

• Hormones

  a maternal saliva sample for hormones was took pretest and posttest (after application in 30 minutes).

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Therapeutic Touch focused on sacral region OTHER

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

Also known as: Placebo Touch (Mimic Touch) focused on sacral region

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıcam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebru Gözüyeşil, PhD. Associate Professor,

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: March 8, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)