Deep Tissue Massage on Pain and Comfort After Cesarean

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457921
• Other study ID #: 2019/57
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cesarean Section
• Comfort
• Massage
• Midwifery
• Pain, Postoperative

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

External Links

•   Reference link