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

Comfort Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062160
• Other study ID #: 10.09.2021/114
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: September 2023
• Source: Cukurova University
• Contact: Meltem Akbas, PhD
• Phone: +905065146780
• Email: makbaskanat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Comfort
• Midwifery
• Postpartum Period
• Therapeutic Touch

Intervention

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

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.