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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04457921
Other study ID # 2019/57
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2019
Est. completion date December 17, 2019

Study information

Verified date July 2020
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 17, 2019
Est. primary completion date November 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Turkey Inonu University Malatya

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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