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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Mobilization

Intervention / Treatment
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* Other: Acupressure
* Other: Plasebo acupressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, parallel, two-arm, randomized controlled clinical trial, double blind
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure Group (experimental)<br>The experimental group will be given acupressure. | Other: Acupressure<br>* 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.<br>* Other names: Acupress;|
| Placebo Comparator: Placebo Acupressure Group (control)<br>The placebo group will be given placebo acupressure. | Other: Plasebo acupressure<br>* 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.<br>* Other names: Placebo Acupress;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluated using the visual analog scale | 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. | Change from before implementation and after 1 minute, 2nd and 4th hour after implementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China) | The number of steps in the first mobilization will be evaluated with a pedometer. | Change 4th hour after acupressure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-cesarean, Acupressure, Pain, Step, Mobilization