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NCT Number: NCT06720077

Effect of Acupressure in The Management of Postmenopausal Constipation

This study was conducted to investigate the effect of acupressure in the management of constipation in postmenopausal women.

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Key information

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo University

Giza, Egypt

Location contact

Manal Ahmed El-Shafei, PhD

CONTACT

Samar Gamal Mohamed Gab Allah, B.Sc

CONTACT

[email protected]

01111660110

About this study

Constipation is prevalent in menopause, affecting 4-29% of women globally, and can lead to serious complications like hemorrhoids, anal fissures, and colorectal cancer. While laxatives can help, long-term use may cause dependency and side effects. Alternative therapies are needed.

Deep breathing, particularly diaphragmatic breathing, may improve constipation by activating the parasympathetic system and promoting relaxation. Acupressure has also shown potential in managing constipation by stimulating intestinal activity, improving blood circulation, and regulating Qi flow.

Despite existing studies on acupressure and constipation, no research has specifically examined its effect on postmenopausal women. This study aims to investigate acupressure's impact on functional constipation in this population, offering potential insights for non-pharmacological management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sixty postmenopausal women who were clinically diagnosed as having functional constipation after menopause (at least one year after the stoppage of the last menstrual cycle)
  • Their ages ranged from 50 to 60 years old.
  • Their body mass index didn't exceed 30 kg/m2.
  • All of them should have at least two criteria of Rome III diagnostic criteria of constipation.
  • They should stop laxatives intake during the treatment program.

Exclusion criteria

  • Irritable bowel syndrome or anal fissures.
  • Genital organ prolapse as rectocele.
  • Any neurological diseases, spinal diseases or spinal deformities.
  • History of bowel surgery.
  • Congenital anorectal malformation, stoma in situ.
  • Diabetes mellitus and sever distal venous insufficiency.
  • Skin eruption at the site of stimulation.
  • Implanted pacemaker or defibrillator.
  • Metalic implant in lower limb.
  • Recent surgery at the lower limb.
  • Peripheral neuropathy and neurological disorders.
  • Psychological distress.

Treatment and study plan

Acupressure

Other

It will be applied for the experimental group only. Before starting the first treatment session, the participants will be instructed briefly about the nature of the treatment to gain their confidence and cooperation. Each participant in this group will be asked to lie in supine position and the acupressure will be applied by using the therapist's fingers on the following acupoints (san jio 6/ spleen 15/ stomach 25/ joining vally " intestine 4") 1 minute for each point with 3 repetitions on both sides (about 30 minutes as total time), 3 times per week for 6 weeks.

Diaphragmatic breathing exercises

Other

A modified exercise will be used to achieve normal diaphragmatic breathing while the woman is lying on her back, with one hand placed on her abdomen and the other on her thorax. She will then be instructed to breathe in deeply, slowly, and gradually for 4 seconds, hold the air for 2 seconds, and exhale slowly through pursed lips for 6 seconds. Three series of ten repetitions will be completed with rest in between; the woman will be advised to rest longer if she feels dizzy or lightheaded. The patient will ensure the exercise is performed successfully if the hand placed on the abdomen shows greater mobility compared to minimal or no mobility of the hand on the thorax. From that point, the series of repetitions will begin.

General bowel care advise

Other

All women in both groups will receive bowel care advice, including encouraging fiber intake (20-35 g/day) from sources like whole grains, fruits, vegetables, and legumes, with a focus on soluble fiber. They will be advised to limit meat, dairy, and low-fiber foods and avoid caffeine-containing products like chocolate and coffee. Adequate hydration (1.5-2.0 L/day) with water or juices will be recommended, along with daily exercise, such as 20-30 minutes of walking. Proper toilet posture will be emphasized, including sitting with knees higher than hips (using a stool if needed), leaning forward, placing elbows on knees, relaxing, and maintaining a straight spine.

Primary outcomes

  1. Patient Assessment of Constipation Symptom (PAC - SYM)

    Time frame: 6 weeks

    It is a reliable and valid tool to measure the patient's perspective constipation symptoms in terms of frequency and severity, It is a 12- item that is divided into three symptom subscales: abdominal (four items); rectal (three items); and stool (five items). Items are scored on 5-point Like scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe'). A mean total score in the range of 0-4 is generated by dividing the total score by the number of questions completed; the lower the total score, the lower the symptom burden.

  2. Patient Assessment of Constipation quality of life (PAC - QOL)

    Time frame: 6 weeks

    The PAC-QOL questionnaire is used to evaluate the quality of life of patients having constipation. It is a brief but comprehensive tool which evaluates constipation through daily individual health assessment and functioning. This questionnaire consists of 28 self-reported items which sub-categorized to 4 items on physical discomfort, 8 items on psychosocial discomfort, 5 items on treatment satisfaction, and finally 11 items on worries and discomfort. Lower scores indicate higher quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Manal Ahmed El-Shafei, PhD

CONTACT

Samar Gamal Mohamed Gab Allah, B.Sc

CONTACT

[email protected]

01111660110

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Dec 11, 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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