Pain ManagementNCT06340776
The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy
A study testing Acupressure in people with Pain Management and Hysterectomy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy. Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Read more about this study
- Who is it for?
- Ages 35 to 80 years, women only
- Conditions the study is for
- Pain Management, Hysterectomy, Vomiting
- What is being tested?
- Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 28 Sep 2023
- 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 35 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with Post hysterectomy operation
- Turkish women over the age of 18 years
- had no wounds or ulcerations in the areas where acupressure would be applied on the arms' legs
- had no intestinal obstruction, irritable bowel syndrome, inflammatory bowel disease, or abdominal herniation due to bowel cancer
- had defecated at least three times a week in the last trimester
- had stools of normal consistency; did not develop any serious postoperative complications
Who cannot join
- had chronicle constipation, fecal incontinence or diarrhea
- who used laxatives, suppositories oath enemas,
- who were immobilized,
- who did not agree to participate in the study,
- who did not speak Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeliz Yildirim Varişoğlu
Istanbul, Beykoz, 34413
About this study
Official title: The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy: a Randomized Controlled Study
Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.
Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection.
Read the detailed description
The study consists of two groups: control and experimental groups. Those who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. The control group was evaluated without any application for two days. For the acupressure application, planning was made to adjust the temperature, light, and silence of the environment and to pay attention to privacy. 5 points that positively affect gastrointestinal functions and pain were selected (SP6, ST36, PC6, HT7, LI4). The duration of the session was determined to be approximately 18-20 minutes, depending on the preparation and pressure time to be applied on the 5 selected points (a total of 10 points were applied since each point will also be applied to its counterpart in the other extremity). Acupressure application was applied to each point for 1.5 minutes (1.5*10=15 minutes). The application was applied to a total of 39 women, 19 experimental and 20 control. No treatment was performed on the women in the control group other than routine post-operative care.
- Conditions
- Pain Management, Hysterectomy, Vomiting
- Being tested
- Acupressure
- Medical subject headings
- Agnosia, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
For the acupressure application, planning was made to adjust the temperature, light and silence of the environment and to pay attention to privacy. 5 points that positively affect gastrointestinal functions and pain were selected (SP6, ST36, PC6, HT7 AND LI4). The duration of the session was determined to be approximately 18-20 minutes, depending on the preparation and pressure time to be applied on the 5 selected points (a total of 10 points were applied since each point will also be applied to its counterpart in the other extremity). Acupressure application was applied to each point for 1.5 minutes (1.5*10=15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | Those who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. Receives: Other: Acupressure |
| Control Group | No intervention | The control group was evaluated for two days without any application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the score of nausea, vomiting and retching experiences
To evaluate the 24-hour nausea and vomiting status, the Rhodes Nausea, Vomiting and Retching Index was used to evaluate postoperative nausea and vomiting.In this scale, the number of nausea, vomiting, and retching of individuals and their distress are measured by Likert type assessment. This five-point Likert-type scale consists of eight items that measure the number and severity of nausea, vomiting, and retching in the last 24 hours. For each response, "never vomited" is scored as "0" or "never felt it", "7 or more" "severe" "more than 6 hours" "too much" is scored as 4. Items 1, 3, 6, and 7 must be reversed to score the Rhodes Index of Nausea, Vomiting, and Retching. The highest value that can be obtained from the scale is 32, meaning that as the score increases, the level of distress also increases. The scale has three subscales: symptom (nausea, vomiting, and retching) experience, occurrence, and distress.
Measured: 18 month
gas output and stool formation of the participants
This is the form in which the patients' bowel sounds, flatulence time are defecation time are recorded for two days after hysterectomy.
Measured: 18 month
postoperative pain
Pain intensity was evaluated with the Numerical Pain Intensity Scale, which is a single-criteria and subjective individual pain assessment method and aims to explain the severity of the patient's pain with numbers. The starting point of the scale, which consists of a horizontal line, is "0" or "no pain", and the ending point is "10" or "unbearable pain".
There are numbers from 0 to 10 at equal intervals on the horizontal line, where 1-3 is defined as mild pain, 4-6 as moderate pain, and 7-10 as severe pain.
Measured: 18 month
Secondary outcomes (3)
Systolic Blood pressure
Postoperative vital signs was evaluated by daily following form
Measured: 18 month
Heart rate
Postoperative vital signs was evaluated by daily following form
Measured: 18 month
Diastolic blood pressure
Postoperative vital signs was evaluated by daily following form
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Aug 2021
- Primary completion20 Jun 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Acupressure groupThose who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. Control group:The control group was evaluated for two days without any application.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YELİZ YILDIRIM VARIŞOĞLU, Istanbul Medipol University Hospital
- Investigators
- MERVE YAVAŞ, Msc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340776
- Sponsor's protocol ID
- 81321
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06340776
- Acronym / sponsor ID
- 81321
- Conditions
- Pain Management, Hysterectomy, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 2 Apr 2024 (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.
Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.
Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection.
Detailed description
The study consists of two groups: control and experimental groups. Those who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. The control group was evaluated without any application for two days. For the acupressure application, planning was made to adjust the temperature, light, and silence of the environment and to pay attention to privacy. 5 points that positively affect gastrointestinal functions and pain were selected (SP6, ST36, PC6, HT7, LI4). The duration of the session was determined to be approximately 18-20 minutes, depending on the preparation and pressure time to be applied on the 5 selected points (a total of 10 points were applied since each point will also be applied to its counterpart in the other extremity). Acupressure application was applied to each point for 1.5 minutes (1.5*10=15 minutes). The application was applied to a total of 39 women, 19 experimental and 20 control. No treatment was performed on the women in the control group other than routine post-operative care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Acupressure groupThose who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. Control group:The control group was evaluated for two days without any application.
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: AcupressureThose who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. |
| Control Group | No intervention | –The control group was evaluated for two days without any application. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women with Post hysterectomy operation
- Turkish women over the age of 18 years
- had no wounds or ulcerations in the areas where acupressure would be applied on the arms' legs
- had no intestinal obstruction, irritable bowel syndrome, inflammatory bowel disease, or abdominal herniation due to bowel cancer
- had defecated at least three times a week in the last trimester
Key exclusion criteria (5 listed)
- had chronicle constipation, fecal incontinence or diarrhea
- who used laxatives, suppositories oath enemas,
- who were immobilized,
- who did not agree to participate in the study,
- who did not speak Turkish.
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 |
|---|---|---|
| AcupressureFor the acupressure application, planning was made to adjust the temperature, light and silence of the environment and to pay attention to privacy. 5 points that positively affect gastrointestinal functions and pain were selected (SP6, ST36, PC6, HT7 AND LI4). The duration of the session was determined to be approximately 18-20 minutes, depending on the preparation and pressure time to be applied on the 5 selected points (a total of 10 points were applied since each point will also be applied to its counterpart in the other extremity). Acupressure application was applied to each point for 1.5 minutes (1.5*10=15 minutes). | Other | Acupressure group |
Primary outcome
the score of nausea, vomiting and retching experiences
Time frame: 18 month
To evaluate the 24-hour nausea and vomiting status, the Rhodes Nausea, Vomiting and Retching Index was used to evaluate postoperative nausea and vomiting.In this scale, the number of nausea, vomiting, and retching of individuals and their distress are measured by Likert type assessment. This five-point Likert-type scale consists of eight items that measure the number and severity of nausea, vomiting, and retching in the last 24 hours. For each response, "never vomited" is scored as "0" or "never felt it", "7 or more" "severe" "more than 6 hours" "too much" is scored as 4. Items 1, 3, 6, and 7 must be reversed to score the Rhodes Index of Nausea, Vomiting, and Retching. The highest value that can be obtained from the scale is 32, meaning that as the score increases, the level of distress also increases. The scale has three subscales: symptom (nausea, vomiting, and retching) experience, occurrence, and distress.
gas output and stool formation of the participants
Time frame: 18 month
This is the form in which the patients' bowel sounds, flatulence time are defecation time are recorded for two days after hysterectomy.
postoperative pain
Time frame: 18 month
Pain intensity was evaluated with the Numerical Pain Intensity Scale, which is a single-criteria and subjective individual pain assessment method and aims to explain the severity of the patient's pain with numbers. The starting point of the scale, which consists of a horizontal line, is "0" or "no pain", and the ending point is "10" or "unbearable pain". There are numbers from 0 to 10 at equal intervals on the horizontal line, where 1-3 is defined as mild pain, 4-6 as moderate pain, and 7-10 as severe pain.
3 secondary outcomes
Systolic Blood pressure
Time frame: 18 month
Heart rate
Time frame: 18 month
Diastolic blood pressure
Time frame: 18 month
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 25 Apr 2024.
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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.
MERVE YAVAŞ, Msc principal investigator
Medipol University
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 Pain Management and Hysterectomy, run by Istanbul Medipol University Hospital 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 6 inclusion and 5 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 25 Apr 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?
the score of nausea, vomiting and retching experiences (time frame: 18 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2024.