Clinical trial NCT06062160: The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section
Official title: The Effect of Therapeutic Touch on Pain and Comfort After Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Touch
Postpartum Period
Midwifery
Comfort
Keywords: Therapeutic Touch
comfort
midwifery
pain
postpartum period
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Measurement was taken half an hour after the intervention.
measure: Postpartum Comfort Scale
timeFrame: Measurement was taken half an hour after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Universty Of Cukurova
name: Meltem Akbaş, PhD
role: PRINCIPAL_INVESTIGATOR
References: