The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy

NCT06340776 | Completed

• 1 other identifier: 81321
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Hysterectomy; Vomiting

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  18 month

Secondary Outcomes (3)

• Systolic Blood pressure

  18 month

• Heart rate

  18 month

• Diastolic blood pressure

  18 month

Study Arms (2)

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.

Other: Acupressure

Control Group

NO INTERVENTION

The control group was evaluated for two days without any application.

Interventions

Acupressure OTHER

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).

Acupressure group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Gender Eligibility Details: Hysterectomy operation can be done in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yeliz Yildirim Varişoğlu

Istanbul, Beykoz, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Vomiting

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• MERVE YAVAŞ, Msc

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Asist.

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: April 2, 2024
• Study Start: August 15, 2021
• Primary Completion: June 20, 2023
• Study Completion: September 28, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

TU (1)