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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06062160
Other study ID # 10.09.2021/114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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.
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