Clinical trial NCT06340776: The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy
Official title: The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Hysterectomy
Vomiting
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the score of nausea, vomiting and retching experiences
timeFrame: 18 month
measure: gas output and stool formation of the participants
timeFrame: 18 month
measure: postoperative pain
timeFrame: 18 month
Secondary outcomes:
measure: Systolic Blood pressure
timeFrame: 18 month
measure: Heart rate
timeFrame: 18 month
measure: Diastolic blood pressure
timeFrame: 18 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeliz Yildirim Varişoğlu
state: Beykoz
Study officials:
affiliation: Medipol University
name: MERVE YAVAŞ, Msc
role: PRINCIPAL_INVESTIGATOR
References: