- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06172439
Effect of Acupressure on Postoperative Pain With Gynecologıcal Surgery
June 25, 2024 updated by: Meliha Dönmez, Saglik Bilimleri Universitesi
The Effect Of Acupressure Applıcatıon On Postoperative Pain Level İn Women With Abdominal Gynecologıcal Surgery: Randomized Controlled Study
In this study, the effect of acupressure on postoperative pain level in women with abdominal gynecologıcal surgery will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other.The sample group will consist of 102 women, 51 in the intervention group and 51 in the control group.Within the scope of the study, the data will be collected using the 'Personal Information Form and Short-Form McGill Pain Questionnaire (SF-MPQ)' created by the researcher.
Data will be analyzed using SPSS-26 package.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this study, the effect of acupressure on postoperative pain level in women with abdominal gynecologıcal surgery will be studied and it will be conducted as a randomized controlled intervention study to examine the relationships with each other.The sample group will consist of 102 women, 51 in the intervention group and 51 in the control group.Within the scope of the study, the data will be collected using the 'Personal Information Form and Short-Form McGill Pain Questionnaire(SF-MPQ)' created by the researcher.
Data will be obtained by the researcher by faceto-face interviews with women.
In addition, women in the intervention group will receive acupressure once on postoperative days 0 and 1. Acupressure points related to gynecological surgery (large intestine (LI4), stomach (ST36) and spleen (SP6)) will be applied for a total of 12 minutes with 2 minutes of pressure on each point.
Women in the control group will continue their routine care.
Data will be evaluated with SPSS-26 package.
Study Type
Interventional
Enrollment (Actual)
102
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
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-
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Ankara, Turkey, 06010
- Faculty of Nursing
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 20 years of age or older,
- Being literate,
- To be able to understand and speak Turkish,
- No deformity or lesion in the areas where acupressure will be applied,
- Undergoing abdominal gynecologic surgery with general anesthesia,
- Any narcotic or epidural for pain control after surgery lack of analgesia
- Participation in the routine pain protocol of the clinic
Exclusion Criteria:
- The presence of any systemic disease that causes chronic pain,
- Receiving spinal or epidural anesthesia,
- Patients who are administered narcotic or any analgesic drug other than the routine pain protocol applied in the clinic after surgery
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: experimental group
Women in the intervention group will receive acupressure for 12 minutes.
|
Women in the intervention group will receive acupressure for 12 minutes.The acupressure pressure points related to the gynecologic surgery to be performed are named as the large intestine (LI4), stomach (ST36) and spleen (SP6) meridians, respectively.
These points are determined by expert opinion and are used for pain control.
|
|
No Intervention: control group
Women in the control group will not receive acupressure and will continue with routine care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain level
Time Frame: 7 month
|
Pain will be measured with the Short-Form McGill pain questionnaire (SF-MPQ) before and after the application
|
7 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meliha Dönmez, Saglik Bilimleri Universitesi
- Study Director: Gülşah Kök, Saglik Bilimleri Universitesi
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
- Borys M, Zyzak K, Hanych A, Domagala M, Galkin P, Galaszkiewicz K, Klaput A, Wroblewski K, Miekina J, Onichimowski D, Czuczwar M. Survey of postoperative pain control in different types of hospitals: a multicenter observational study. BMC Anesthesiol. 2018 Jul 18;18(1):83. doi: 10.1186/s12871-018-0551-3.
- Mehta P, Dhapte V, Kadam S, Dhapte V. Contemporary acupressure therapy: Adroit cure for painless recovery of therapeutic ailments. J Tradit Complement Med. 2016 Jul 22;7(2):251-263. doi: 10.1016/j.jtcme.2016.06.004. eCollection 2017 Apr.
- Kidanemariam BY, Elsholz T, Simel LL, Tesfamariam EH, Andemeskel YM. Utilization of non-pharmacological methods and the perceived barriers for adult postoperative pain management by the nurses at selected National Hospitals in Asmara, Eritrea. BMC Nurs. 2020 Oct 22;19:100. doi: 10.1186/s12912-020-00492-0. eCollection 2020.
- Bernardinelli N, Valery A, Barrault D, Dorland JM, Palut P, Toumi H, Lespessailles E. Effectiveness of Shiatsu on Fatigue in Patients with Axial Spondyloarthritis: Protocol for a Randomized Cross-Over Pilot Study. Rheumatol Ther. 2023 Aug;10(4):1107-1117. doi: 10.1007/s40744-023-00558-w. Epub 2023 May 12.
- Erden S, Guler S, Tura I, Basibuyuk IF, Arslan UE. Evaluating patient outcomes in postoperative pain management according to the revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). Appl Nurs Res. 2023 Oct;73:151734. doi: 10.1016/j.apnr.2023.151734. Epub 2023 Aug 18.
- Mohd Nafiah NA, Chieng WK, Zainuddin AA, Chew KT, Kalok A, Abu MA, Ng BK, Mohamed Ismail NA, Nur Azurah AG. Effect of Acupressure at P6 on Nausea and Vomiting in Women with Hyperemesis Gravidarum: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 1;19(17):10886. doi: 10.3390/ijerph191710886.
- Noll E, Shodhan S, Romeiser JL, Madariaga MC, Page C, Santangelo D, Guo X, Pryor AD, Gan TJ, Bennett-Guerrero E. Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):557-565. doi: 10.1097/EJA.0000000000001001.
- Alimoradi Z, Kazemi F, Valiani M, Gorji M. Comparing the effect of auricular acupressure and body acupressure on pain and duration of the first stage of labor: study protocol for a randomized controlled trial. Trials. 2019 Dec 23;20(1):766. doi: 10.1186/s13063-019-3896-0.
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 1, 2023
Primary Completion (Actual)
December 30, 2023
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
December 7, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 15, 2023
Study Record Updates
Last Update Posted (Actual)
June 26, 2024
Last Update Submitted That Met QC Criteria
June 25, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU-MDONMEZ-001
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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