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

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.

Study Overview

• Status: Recruiting
• Conditions: Comfort; Therapeutic Touch; Midwifery; Postpartum Period
• Intervention / Treatment: Other: Therapeutic Touch

Detailed Description

Cesarean section rate is increasing in the world and in our country, and it might bring other problems with it. Pain, breastfeeding problems and decrease in comfort problems have high chance to happen after cesarean section. The insufficiency of pharmacological methods in reducing the problems experienced after cesarean section and having many side effects increase the using percentage tendency to non-pharmacological methods.

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem Akbaş, PhD; Phone Number: +905065146780; Email: makbaskanat@gmail.com
• Study Contact Backup: Name: Büşra Karaaslan, Msc student; Phone Number: +905536080516; Email: bsrkarsln@gmail.com

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Recruiting
    • Cukurova University
    • Contact: Meltem Akbaş, PhD; Phone Number: +905065146780; Email: makbaskanat@gmail.com
    • Contact: Meltem Akbaş, PhD; Phone Number: 05065146780; Email: makbaskanat@gmail.com
    • Sub-Investigator: Büşra Karaaslan, Msc student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Experimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section.	Other: Therapeutic Touch; Experimental group received deep Therapeutic Touch two time at 10th and 40nd hours after cesarean section.
No Intervention: Control; There will be no intervention in the control group. Routine maintenance will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Cukurova University
• Investigators: Principal Investigator: Meltem Akbaş, PhD, Universty Of Cukurova

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pain; comfort; Therapeutic Touch; midwifery; postpartum period
• Other Study ID Numbers: 10.09.2021/114

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