The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section

NCT06062160 | Completed

• 1 other identifier: 10.09.2021/114
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted as randomized controlled study to evaluate the effect of Therapeutic Touch on acute pain and comfort level in women who delivered by cesarean section. Personal information form was used as data collection form, VAS was used to assess pain, and PPCQ was used to assess comfort. When power analysis was performed, the sample size was calculated to be at least 45 participants for each group (45 experiments, 45 controls). Experimental group received deep Therapeutic Touch by investigators two time at 10th and 40nd hours after cesarean section.

Conditions

Therapeutic Touch; Postpartum Period; Midwifery; Comfort

Keywords

Therapeutic Touch; comfort; midwifery; pain; postpartum period

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  The scale is scored between 0-10 points. As the score increases, the pain increases.

  Measurement was taken half an hour after the intervention.

• Postpartum Comfort Scale

  The scale is scored between 34 and 170 points. As the score increases, comfort increases.

  Measurement was taken half an hour after the intervention.

Study Arms (2)

Experimental

EXPERIMENTAL

Experimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section.

Other: Therapeutic Touch

Control

NO INTERVENTION

There will be no intervention in the control group. Routine maintenance will be given.

Interventions

Therapeutic Touch OTHER

Experimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section.

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Those between the ages of 18 and 45
• Multiparous women
• At the 8th postoperative hour
• Women who have not developed any complications during pregnancy, birth and postpartum for themselves or their newborns.
• Having a single, healthy newborn at term,
• Does not react negatively to any attempt to touch,
• Able to speak and communicate in Turkish
• Agreeing to participate in the study

You may not qualify if:

• Those with any problems diagnosed before or at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
• Those who develop any complications related to mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.).
• Those who receive different analgesics other than routine post-operative analgesics (75 mg diclofenac sodium in the first 30 minutes post-op).

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Meltem Akbaş, PhD

  Universty Of Cukurova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: There is a difference between the posttest pain scores of the intervention group and the control group. There is a difference between the comfort level posttest scores of the intervention group and the control group.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 2, 2023
• Study Start: January 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: January 1, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)