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Completed

NCT Number: NCT06340776

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

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.

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Key information

Conditions

Pain Management Agnosia Hysterectomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

35 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yeliz Yildirim Varişoğlu

Istanbul, Beykoz, 34413, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Systolic Blood pressure

    Time frame: 18 month

    Postoperative vital signs was evaluated by daily following form

  2. Heart rate

    Time frame: 18 month

    Postoperative vital signs was evaluated by daily following form

  3. Diastolic blood pressure

    Time frame: 18 month

    Postoperative vital signs was evaluated by daily following form

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy: a Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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