AcupressureNCT06172439
Effect of Acupressure on Postoperative Pain With Gynecologıcal Surgery
A study testing acupressure in people with Acupressure and Post Operative Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acupressure, Post Operative Pain, Nurse's Role
- What is being tested?
- acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acupressure, Post Operative Pain, Nurse's Role
- Being tested
- acupressure
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Women in the intervention group will receive acupressure for 12 minutes. Receives: Other: acupressure |
| control group | No intervention | Women in the control group will not receive acupressure and will continue with routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain level
Pain will be measured with the Short-Form McGill pain questionnaire (SF-MPQ) before and after the application
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AcupressureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized controlled intervention trial
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meliha Dönmez, Saglik Bilimleri Universitesi
- Investigators
- Meliha Dönmez, Principal investigator, Saglik Bilimleri UniversitesiGülşah Kök, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172439
- Sponsor's protocol ID
- SBU-MDONMEZ-001
- Status last verified
- Jun 2024
- First submitted
- 7 Dec 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33110397Bernardinelli 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.
PubMed 37173568Mehta 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.
PubMed 28417094Borys 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.
PubMed 30021520Erden 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.
PubMed 37722782Mohd 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.
PubMed 36078602Noll 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.
PubMed 30985537Alimoradi 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.
PubMed 31870458
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Acupressure Applıcatıon On Postoperative Pain Level İn Women With Abdominal Gynecologıcal Surgery: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06172439
- Acronym / sponsor ID
- SBU-MDONMEZ-001
- Conditions
- Acupressure, Post Operative Pain, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized controlled intervention trial
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: acupressureWomen in the intervention group will receive acupressure for 12 minutes. |
| control group | No intervention | –Women in the control group will not receive acupressure and will continue with routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupressureWomen 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. | Other | experimental group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 33110397Kidanemariam 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.
- Background: PubMed 37173568Bernardinelli 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.
- Background: PubMed 28417094Mehta 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.
- Background: PubMed 30021520Borys 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.
- Background: PubMed 37722782Erden 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.
- Background: PubMed 36078602Mohd 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.
- Background: PubMed 30985537Noll 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.
- Background: PubMed 31870458Alimoradi 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.
- Individual participant dataSharing planned: No
Related trials for Acupressure
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Not yet recruiting
Battlefield Acupressure for Acute Back Pain Management in the Emergency Department
Acute Back Pain
Recruiting
Acupressure as Complementary Analgesia in Shock Wave Lithotripsy
Acupressure, Urinary Calculi
Not yet recruiting
Self-administered Acupressure in Patients With Sickle Cell Disease
Sickle Cell Disease (SCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meliha Dönmez principal investigator
Saglik Bilimleri Universitesi
Gülşah Kök study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Acupressure and Post Operative Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain level (time frame: 7 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06172439, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.