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

Sponsor
Cukurova University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06062160
Collaborator
(none)
90
1
2
24
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic Touch
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Masking Description:
Single blind
Primary Purpose:
Prevention
Official Title:
The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale [Measurement was taken half an hour after the intervention.]

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

  2. Postpartum Comfort Scale [Measurement was taken half an hour after the intervention.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cukurova University Adana Turkey 01330

Sponsors and Collaborators

  • Cukurova University

Investigators

  • Principal Investigator: Meltem Akbaş, PhD, Universty Of Cukurova

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meltem Akbaş, Assistant Professor, Cukurova University
ClinicalTrials.gov Identifier:
NCT06062160
Other Study ID Numbers:
  • 10.09.2021/114
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 2, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Meltem Akbaş, Assistant Professor, Cukurova University

Study Results

No Results Posted as of Oct 2, 2023