Healthy female volunteer study to examine the effect of different body positions and environment on defecation physiology

Not Applicable

Recruiting

• Conditions: Constipation - Dyssynergic defecation; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12623000471684
• Lead Sponsor: Royal North Shore Hospital - Northern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-09
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1)Age 20 to 75
2)Females
3)English speakers
4)Patients who are eligible for Medicare benefit in Australia
5)Willingness to answer screening questionnaire
6)Willingness to give written informed consent
7)Willingness to comply with the study.

Exclusion Criteria

1)Women breast feeding or pregnant.
2)Definable gastrointestinal disorder based on the ROME questionnaire : Disorders excluded: Irritable bowel syndrome, functional bloating, functional constipation or diarrhoea, abdominal pain and functional anorectal disorders.
3)Presence of overt organic anorectal disorder
4)Medications that alter motility of the GI tract, such as loperamide and opioids
5)History of anorectal or distal colon surgery.
6)History of complicated vaginal delivery
7)History of psychological illness or condition such as interfere with the patient’s ability to understand the requirements of the study. This will be assessed by: (a) hospital anxiety and depression score, (b) screening questionnaire questions about medical conditions and current medications, and (c) brief physician interview and discussion of patient information and consent form before patients consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Balloon expulsion time measured using stopwatch[ At the time of intervention]

Secondary Outcome Measures

Name	Time	Method
Ease and comfort of balloon expulsion will be rated by participants on a ten point visual analogue scale. After each position/environments has been tested, participants will be asked to give score out of 10. Then this response will be recorded on the result sheet by the investigator.<br><br>After completing all three positions/environments have been tested, Participants will be asked to choose the position/environment that was the most easy and comfortable. Then this response will be recorded on the result sheet by the investigator.[ At the time of intervention]