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Completed

NCT Number: NCT05311449

The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance

This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

About this study

Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being conscious,
  • The mother tongue is Turkish,
  • To be oriented and cooperative,
  • be between 18-45 years old,
  • To voluntarily agree to participate in the study (signing the Informed Consent Form),
  • Repeated cesarean section,
  • Cesarean section under spinal anesthesia,
  • Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
  • No health problems of the fetus,
  • To have given birth by cesarean section between 37-40 weeks,
  • To be in the second hour of the postpartum period,
  • Not receiving post-op patient-controlled analgesia,
  • Not to have smoked or used alcohol during pregnancy,
  • No complications in the mother and/or newborn after cesarean section,
  • No sensitivity in the area where acupressure will be applied,
  • Absence of any systemic or psychiatric diagnosis,
  • Absence of active COVID-19 infection.

Exclusion criteria

  • Lack of consciousness,
  • The mother tongue is not Turkish,
  • Not oriented and cooperative,
  • Not to be between the ages of 18-45,
  • Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
  • Normal birth or cesarean delivery under general anesthesia,
  • Cesarean delivery due to the risk of deterioration of maternal or fetal health,
  • Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
  • Not giving birth outside 37-40 weeks and by cesarean section,
  • Not in the second hour of the postpartum period,
  • Receiving post-op patient-controlled analgesia,
  • To have used cigarettes and alcohol during pregnancy,
  • Sensitivity in the area where acupressure will be applied,
  • Presence of any systemic or psychiatric diagnosis,
  • Active COVID-19 infection.

Treatment and study plan

Acupressure

Other

The experimental group will start with LI4 points, and continue with P6 and SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.

Other names: Acupress

Plasebo acupressure

Other

In the control group, the application will start with the points 1.5 cm around the LI4, P6 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.

Other names: Placebo Acupress

Primary outcomes

  1. Pain evaluated using the visual analog scale

    Time frame: Change from before implementation and after 1 minute, 2nd and 4th hour after implementation

    The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.

Secondary outcomes

  1. The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)

    Time frame: Change 4th hour after acupressure

    The number of steps in the first mobilization will be evaluated with a pedometer.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study

Acronym: Acupress

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Sep 27, 2022

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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