Deep Tissue Massage on Pain and Comfort After Cesarean

Effects of Deep Tissue Massage on Pain and Comfort After Cesarean: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Cesarean Section; Massage; Comfort; Midwifery
• Intervention / Treatment: Other: deep tissue massage

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey
    • İnonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep tissue massage; deep tissue massage applied group	Other: deep tissue massage; DTM was applied to participants in the experimental group twice (at the 10th and 22nd h) after cesarean
No Intervention: Standard of care; group without deep tissue massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scores	Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm	at 11st hours cesarean section
pain scores	Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm	at 23rd hours cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comfort scores	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.	at 23rd hours cesarean section

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: ESRA GUNEY, İnonu University

Publications and helpful links

General Publications

• Simonelli MC, Doyle LT, Columbia M, Wells PD, Benson KV, Lee CS. Effects of Connective Tissue Massage on Pain in Primiparous Women After Cesarean Birth. J Obstet Gynecol Neonatal Nurs. 2018 Sep;47(5):591-601. doi: 10.1016/j.jogn.2018.07.006. Epub 2018 Aug 11.

Helpful Links

• Reference link

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2019
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2019/57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: research results will be shared.

Study Data/Documents

1. Study Protocol
   Information identifier: Mary Colleen Simonelli
   Information comments: web site is provided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No