- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06340776
The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beykoz
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Istanbul, Beykoz, Turkey, 34413
- Yeliz Yildirim Varişoğlu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Acupressure group
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.
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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).
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No Intervention: Control Group
The control group was evaluated for two days without any application.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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the score of nausea, vomiting and retching experiences
Time Frame: 18 month
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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.
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18 month
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gas output and stool formation of the participants
Time Frame: 18 month
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This is the form in which the patients' bowel sounds, flatulence time are defecation time are recorded for two days after hysterectomy.
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18 month
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postoperative pain
Time Frame: 18 month
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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. |
18 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: 18 month
|
Postoperative vital signs was evaluated by daily following form
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18 month
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Systolic Blood pressure
Time Frame: 18 month
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Postoperative vital signs was evaluated by daily following form
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18 month
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Diastolic blood pressure
Time Frame: 18 month
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Postoperative vital signs was evaluated by daily following form
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18 month
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Collaborators and Investigators
Investigators
- Principal Investigator: MERVE YAVAŞ, Msc, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81321
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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