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Deep Tissue Massage on Pain and Comfort After Cesarean

Primary Purpose

Cesarean Section, Pain, Postoperative, Massage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
deep tissue massage
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Deep tissue massage

Standard of care

Arm Description

deep tissue massage applied group

group without deep tissue massage

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
June 29, 2020
Last Updated
July 3, 2020
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04457921
Brief Title
Deep Tissue Massage on Pain and Comfort After Cesarean
Official Title
Effects of Deep Tissue Massage on Pain and Comfort After Cesarean: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Pain, Postoperative, Massage, Comfort, Midwifery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep tissue massage
Arm Type
Experimental
Arm Description
deep tissue massage applied group
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
group without deep tissue massage
Intervention Type
Other
Intervention Name(s)
deep tissue massage
Intervention Description
Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section.
Primary Outcome Measure Information:
Title
pain scores
Description
Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm
Time Frame
at 11st hours cesarean section
Title
pain scores
Description
Visual Analog Scale: Mild pain between 0-44 mm, moderate pain between 45-74 mm, and severe pain between 75-100 mm
Time Frame
at 23rd hours cesarean section
Secondary Outcome Measure Information:
Title
comfort scores
Description
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.
Time Frame
at 23rd hours cesarean section

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ESRA GUNEY
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
research results will be shared.
Citations:
PubMed Identifier
30102886
Citation
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.
Results Reference
result
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/30102886/
Description
Reference link
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://pubmed.ncbi.nlm.nih.gov/30102886/
Available IPD/Information Identifier
Mary Colleen Simonelli
Available IPD/Information Comments
web site is provided

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Deep Tissue Massage on Pain and Comfort After Cesarean

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