Automatic abdominal/waist massage for managing chronic constipation in older adults

ISRCTN	ISRCTN15361893
DOI	https://doi.org/10.1186/ISRCTN15361893
Secondary identifying numbers	Nil Known

Submission date: 29/05/2025
Registration date: 30/05/2025
Last edited: 30/05/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study aims to determine whether combining lifestyle education with the use of a heated massage device applied to the waist and abdomen can help relieve chronic constipation symptoms in older adults.

Who can participate?
We plan to recruit 90 individuals aged 65 and above who have symptoms of chronic constipation, as defined by the Rome IV criteria. Participants will be recruited from community-based long-term care facilities and the district public health center.

What does the study involve?
Participants will be randomly assigned to one of two groups:
Experimental group: Will receive lifestyle education on managing constipation and use a certified heated massager (BSMI certification number R53615) designed for safe use on the waist and abdomen. This device provides gentle heat at approximately 40 °C and features rotating rollers to massage these areas.
Control group: Will receive the same lifestyle education and use a certified heating pad (BSMI certification number R54317) designed for safe use on the waist and abdomen. This device provides gentle heat at approximately 40 °C to warm these areas but does not offer massage.
The intervention will last for four weeks, with sessions conducted five days per week. Each session will consist of 30 minutes, and participants can perform it either at home or at the facility. Before the intervention, we will collect baseline data and interview participants about their experiences with constipation. We will assess outcomes such as bowel movement frequency, use of laxatives, quality of life, and any side effects. Follow-up interviews will compare participants' experiences with the intervention to their previous constipation management strategies.

What are the possible benefits and risks of participating?
Participants may experience improved bowel movements, relief from constipation symptoms, and reduced reliance on laxatives. Potential risks are minimal but may include mild discomfort from the massage or heat application.

Where is the study run from?
The study is being conducted in community-based long-term care facilities and the District Public Health Center in Taichung City, Taiwan.

When is the study starting and how long is it expected to run for?
The study is expected to start in January 2025 and will run for approximately 18 months, including recruitment, intervention, and follow-up.

Who is funding the study?
This study is initiated and funded by the principal investigator, Shiou Yung Huang.

Who is the main contact?
For more information, please contact:
Shiou-Yun Huang, PhD Candidate, Department of Nursing, National Yang Ming Chiao Tung University; Principal Investigator
Email: syhuang02@asia.edu.tw
Professor Li-Yin Chien, Dean, College of Nursing, National Yang Ming Chiao Tung University; Chief Investigator
Email: lychien@nycu.edu.tw

Contact information

Mrs Shiou Yun Huang
Public, Scientific

No. 500, Lioufong Rd., Wufeng, Taichung
Taichung
41354
Taiwan

Phone	+886-4-23323456 ext.20100
Email	syhuang02@asia.edu.tw

Prof Li Yin Chien
Scientific, Principal Investigator

No.155, Sec. 2, Linong St., Beitou Dist.
Taipei City
112304
Taiwan

ORCID ID	0000-0002-4210-2975
Phone	+886-2-28267142
Email	lychien@nycu.edu.tw

Study information

Study design	Two-arm parallel-group randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Care home, Community, Home
Study type	Treatment
Participant information sheet	Not avaliable in web format, please use contact details to request a participant information on sheet.
Scientific title	Effects of automatic abdominal/waist massage in management of chronic constipation among older adults
Study acronym	EAMCOA
Study objectives	Automatic abdominal/waist massage may stimulate intestinal peristalsis and relieve constipation symptoms in elderly individuals.
Ethics approval(s)	Approved 07/01/2025, Institutional Review Board A of National Yang Ming Chiao Tung University (No. 155, Sec. 2, Linong St. Beitou Dist., Taipei City, 112304, Taiwan; +886-2-28239753; irb.ym@nycu.edu.tw), ref: NYCU113084AF
Health condition(s) or problem(s) studied	Constipation
Intervention	Participants were randomized into experimental and control groups. The experimental group received lifestyle modification education for constipation and a warm electric massage applied to the abdomen and waist. The control group received the same lifestyle education and warm compresses applied to the abdomen and waist. The intervention lasted four weeks, with sessions conducted five days per week. Each session included a 30-minute treatment, allocating 15 minutes each to the abdominal and waist regions.
Intervention type	Mixed
Primary outcome measure	Data are collected at baseline (one week before the intervention) and at the end of the fourth intervention week, using questionnaires, participant diaries, a stethoscope, and face-to-face interviews 1. Spontaneous bowel movement frequency per week 2. The Bristol Stool Form Scale 2. Patient Assessment of Constipation Symptoms, PAC-SYM 3. Bowel sounds per minute 4. Adverse events
Secondary outcome measures	Data are collected at baseline (one week before the intervention) and at the end of the fourth intervention week, using questionnaires, participant diaries, and MEAD meridian energy analysis device to evaluate participants’ energy balance, and face-to-face interviews. The MEAD meridian energy device is certified under Taiwan FDA Medical Device License No. 002062. 1. Laxative usage 2. Patient Assessment of Constipation Quality of Life 3. Meridian energy
Overall study start date	03/10/2024
Completion date	14/06/2026

Eligibility

Participant type(s)	Patient
Age group	Senior
Lower age limit	65 Years
Upper age limit	90 Years
Sex	Both
Target number of participants	90
Key inclusion criteria	Adults aged 65 years and above who meet the Rome IV criteria for functional constipation.
Key exclusion criteria	1. Presence of tumors or vascular malformations in the lumbar or abdominal regions. 2. Cognitive impairment indicated by a score of less than 6 on the Short Portable Mental Status Questionnaire (SPMSQ). 3. Skin infections, injuries, bleeding, or thrombophlebitis in areas surrounding the lumbar or abdominal regions that may contraindicate massage therapy. 4. History of abdominal surgery within the past six months. 5. Diagnosed coagulation disorders or platelet function abnormalities. 6. Use of a cardiac pacemaker. 7. Osteoporosis requiring medical treatment.
Date of first enrolment	07/01/2025
Date of final enrolment	14/05/2026

Locations

Countries of recruitment

Taiwan

Study participating centres

Wufeng District Public Health Center

No. 1-9, Minsheng Rd., Wufeng Dist., Taichung City
Taichung City
413006
Taiwan

Enoch Peaceful Residence Community Long-Term Care Facility

Yongchun East 7th Road, Nantun District
Taichung City
408
Taiwan

Sponsor information

National Yang Ming Chiao Tung University
University/education

No.155, Sec. 2, Linong St., Beitou Dist.
Taipei City
112304
Taiwan

Phone	+886-2-2826-7000
Email	lychien@nycu.edu.tw
Website	https://www.nycu.edu.tw/
"ROR"	https://ror.org/00se2k293

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	14/05/2027
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	1. The research findings are planned to be presented orally at an international conference. 2. The results of this study will be submitted to high-impact international journals.
IPD sharing plan	The individual participant data (IPD) collected during this study will not be made publicly available due to concerns regarding participant confidentiality. Given the sensitive nature of the data, there is a risk of re-identification. All data will be securely stored on encrypted servers at National Yang Ming Chiao Tung University and will be accessible only to authorized personnel.

Editorial Notes

29/05/2025: Trial's existence confirmed by Institutional Review Board A of National Yang Ming Chiao Tung University.