- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05311449
The Effect of Post-Cesarean Section Acupressure on the Severity of Pain and First Mobilization Distance (Acupress)
September 23, 2022 updated by: Tugba CAM YANIK, Mersin University
The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenişehir
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Mersin, Yenişehir, Turkey, 33343
- Mersin University
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acupressure Group (experimental)
The experimental group will be given acupressure.
|
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:
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Placebo Comparator: Placebo Acupressure Group (control)
The placebo group will be given placebo acupressure.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
Time Frame: Change 4th hour after acupressure
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The number of steps in the first mobilization will be evaluated with a pedometer.
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Change 4th hour after acupressure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Duygu VEFİKULUÇAY YILMAZ, Doctorate, Mersin University
- Principal Investigator: Aslıhan AKSU, master, Mersin University
- Principal Investigator: Filiz DEĞİRMENCİ, master, Mersin University
- Principal Investigator: Gülay ALTUN UĞRAŞ, doctorate, Mersin University
- Principal Investigator: Mürşide ÇEVİKOĞLU KILLI, doctorate, Mersin City Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chen Y, Xiang XY, Chin KHR, Gao J, Wu J, Lao L, Chen H. Acupressure for labor pain management: a systematic review and meta-analysis of randomized controlled trials. Acupunct Med. 2021 Aug;39(4):243-252. doi: 10.1177/0964528420946044. Epub 2020 Aug 18.
- Smith CA, Collins CT, Levett KM, Armour M, Dahlen HG, Tan AL, Mesgarpour B. Acupuncture or acupressure for pain management during labour. Cochrane Database Syst Rev. 2020 Feb 7;2(2):CD009232. doi: 10.1002/14651858.CD009232.pub2.
- Akgun M, Boz I. The effects of acupressure on post-cesarean pain and analgesic consumption: a randomized single-blinded placebo-controlled study. Int J Qual Health Care. 2020 Nov 16;32(9):609-617. doi: 10.1093/intqhc/mzaa107.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2022
Primary Completion (Actual)
June 26, 2022
Study Completion (Actual)
July 22, 2022
Study Registration Dates
First Submitted
March 27, 2022
First Submitted That Met QC Criteria
March 27, 2022
First Posted (Actual)
April 5, 2022
Study Record Updates
Last Update Posted (Actual)
September 27, 2022
Last Update Submitted That Met QC Criteria
September 23, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Mersin Universit
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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