NCT04457921

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

March 13, 2024

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

June 29, 2020

Last Update Submit

March 12, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • comfort scores

    at 23rd hours cesarean section

Study Arms (2)

Deep tissue massage

EXPERIMENTAL

deep tissue massage applied group

Other: deep tissue massage

Standard of care

NO INTERVENTION

group without deep tissue massage

Interventions

DTM was applied to participants in the experimental group twice (at the 10th and 22nd h) after cesarean

Deep tissue massage

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • ESRA GUNEY

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 7, 2020

Study Start

May 10, 2019

Primary Completion

November 25, 2019

Study Completion

December 17, 2019

Last Updated

March 13, 2024

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

research results will be shared.

Available IPD Datasets

Study Protocol (Mary Colleen Simonelli)Access

Locations