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Completed

NCT Number: NCT04457921

Deep Tissue Massage on Pain and Comfort After Cesarean

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deep Tissue Massage

Other

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

Primary outcomes

  1. pain scores

    Time frame: at 11st hours cesarean section

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

  2. pain scores

    Time frame: at 23rd hours cesarean section

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

Secondary outcomes

  1. comfort scores

    Time frame: at 23rd hours cesarean section

    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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2020
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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