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Deep Tissue Massage on Pain and Comfort After Cesarean

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT04457921
Collaborator
(none)
81
Enrollment
1
Location
2
Arms
7.3
Actual Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study to determine the effect of deep tissue massage applied to the back on pain and comfort after cesarean section. Personal information form was used as data collection form, Visual Analog Scala was used to assess pain, and Postpartum Comfort Questionnaire was used to assess comfort.

Condition or Disease Intervention/Treatment Phase
  • Other: deep tissue massage
 N/A

Detailed Description

Material and Method

This research was conducted between May 2019 and November 2019 in Inonu University Turgut Ozal Medical Center Training and Research Hospital. When power analysis was performed, the sample size was calculated to be at least 81 women for each group (81 experiments, 81 controls). Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section. Data collection form for experimental and control groups before the first massage; Visual Analog Scala was applied four times before and after both massages. After the second massage, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effects of Deep Tissue Massage on Pain and Comfort After Cesarean: A Randomized Controlled Trial
Actual Study Start Date :
May 10, 2019
Actual Primary Completion Date :
Nov 25, 2019
Actual Study Completion Date :
Dec 17, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deep tissue massage

deep tissue massage applied group

Other: deep tissue massage
Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section.
No Intervention: Standard of care

group without deep tissue massage

Outcome Measures

Primary Outcome Measures

  1. pain scores [at 11st hours cesarean section]

    Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm

  2. pain scores [at 23rd hours cesarean section]

    Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm

Secondary Outcome Measures

  1. comfort scores [at 23rd hours cesarean section]

    Postpartum Comfort Questionnaire: The highest score from the scale is 170, the lowest score is 34. The increase in the average score obtained from the scale indicates that the comfort level also increases.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Pain severity is 45 mm or more according to the Visual Analogue Scale (VAS),

  • Having a single and healthy newborn,

  • Does not respond negatively to any attempt to touch like massage,

  • Women whose tissue integrity is complete and healthy in the area to be massaged were included in the sample.

Exclusion Criteria:

  • Those with cesarean section with general anesthesia,

  • Any problems diagnosed before birth and at birth (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)

  • Any complications related to the mother and baby in the postpartum period (bleeding, hypertension, babies taken to the neonatal intensive care unit, etc.),

  • Those who received repeat doses other than routine narcotic analgesics (0.5 mg in the first 30 minutes) were not included in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu University Malatya Turkey

Sponsors and Collaborators

  • Inonu University

Investigators

  • Principal Investigator: ESRA GUNEY, Inonu University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
ESRA GUNEY, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier:
NCT04457921
Other Study ID Numbers:
  • 2019/57
First Posted:
Jul 7, 2020
Last Update Posted:
Jul 7, 2020
Last Verified:
Jul 1, 2020
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
Additional relevant MeSH terms:
Pain, Postoperative

Study Results

No Results Posted as of Jul 7, 2020