The effect of abdominal heat therapy on the improvement of constipation and pain in the elderly admitted to the internal ward
Design
A clinical trial with a control group, with parallel groups, randomized, on 90 patients (in two groups of 45).
Settings and conduct
The patients of the internal ward of Sina Arak Hospital, who having Inclusion criteria, will be randomly assigned to the intervention and control groups by the random block method, and heat therapy intervention will be performed for them. Meals will be the same for all patients (due to the privateness of the hospital, snacks will be given to patients). Blinding is not done in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cognitive health with a score higher than 7 in Abbreviated Mental Test, Hospitalization in the internal ward and having a diagnosis of constipation with the Bristol Stool Scale.
exclusion criteria: having any clinical conditions that would limit the use of local heat therapy based on physician's opinion.
Intervention groups
For the intervention group, two times of heat therapy, 60-90 minutes after lunch and dinner, with a hot bag wrapped in a towel at a temperature of 50 Celsius, will be placed on the abdomen in the periumbilical area for 23 minutes, and in two days, a total of 4 times each patient will receive the hot water bag. For the control group, a hot bag with a 25 Celsius will be administered exactly under the same conditions as the intervention group.
Main outcome variables
Change in defecation and pain during defecation in hospitalized elderly patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170313033047N3
Registration date:2023-06-18, 1402/03/28
Registration timing:registered_while_recruiting
Last update:2023-06-18, 1402/03/28
Update count:0
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
Maryam Jadid Milani
Name of organization / entity
Nursing Faculty of Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 6641 8589
Email address
milani@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-14, 1402/03/24
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of abdominal Thermotherapy on constipation and painful defecation in hospitalized elderly
Public title
The effect of abdominal Thermotherapy on constipation and painful defecation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over 60 years
Cognitive health with a score higher than 7 in Abbreviated Mental Test(AMTs)
Hospitalization in the internal department due to internal and infectious diseases based on clinical and paraclinical findings with the diagnosis of a specialist and having constipation
Movement pattern of relative bed rest (RBR) according to the physician's order written in the file
Having a stable physiological state to answer questions
Exclusion criteria:
having any clinical conditions that doubt or limit the use of local heat therapy, based on physician's order.
Having alcohol and drug addiction
Having psychological disorders recorded in the file
Having swelling, ulcers, scratches and redness in the abdomen
Having history of abdominal and pelvic surgery
Having gastrointestinal diseases and ulcers (from beginning to end)
Taking drugs effective on bowel movements in the last two weeks
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation by random block method (blocks of four).
Blocking is usually used in order to create a balance in the number of samples assigned to each of the studied groups. This feature helps the researchers to ensure that the number of samples allocated to each of the studied groups is equal in cases where intermediate analyzes are needed during the sampling process.
The samples are assigned to intervention and control groups by blocking randomization method with blocks of 4. Block randomization is used in an online generator: "https://www.sealedenvelope.com/simple-randomiser/v1/lists". To conceal the allocation, each of the randomly created sequences is written on a card and placed in an opaque and sealed envelope. At the time of registration of the participants, based on the order of entry of the eligible participants, the envelopes will be opened in order and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.SHAHED.REC.1401.165
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Changing the pattern of defecation
Timepoint
Before the intervention, the first and second days of the intervention
Method of measurement
Bristol stool scale
2
Description
Change in pain during defecation
Timepoint
Before the intervention, the first and second days of the intervention
Method of measurement
Numerical scale for pain intensity measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine intervention for constipation will be performed for all patients based on the physician's order. For the intervention group, two times of heat therapy and each time, two times of heat therapy 60-90 minutes after having lunch and evening meal (according to the hospital routine) with a hot water bag in which water is poured and then the hot water bag putting in the water for 60 to 90 Celsius and when they are heated, it is wrapped in a towel that reaches a temperature of 50 Celsius, the temperature of which is controlled by a thermometer, and the hot water bag will be placed on the abdomen, in the periumbilical area, for 23 minutes, and the intervention will take place in two days. Each patient will receive the hot water bag a total of 4 times. Meals will be the same for all patients (due to the private nature of the hospital, snacks will be given to patients and they will receive less food from outside) and have the same movement pattern.
Category
Treatment - Other
2
Description
Control group: For all patients, routine intervention for constipation will be performed based on physician's order. For the control group, a hot water bag with a temperature of 25 Celsius, which is determined by a thermometer, wrapped in a towel and placed on the abdomen of the patients in the periumbilical area, exactly with the schedule is similar to the intervention group. Meals will be the same for all patients (due to the private nature of the hospital, snacks will be given to patients and they will receive less food from outside) and have the same movement pattern.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Arak city
Full name of responsible person
Maryam Jadid-Milani
Street address
The end of Hepko St., Shahidan Rajaei Blvd., next to Sadeghieh. Arak, Markazi Province, Iran.
City
Arak
Province
Markazi
Postal code
3818853558
Phone
+98 86 3340 5176
Fax
+98 86 3340 5176
Email
automation@araksinahospital.ir
Web page address
https://araksinahospital.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr.Shariyar Bijani
Street address
Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini. Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5105
Fax
+98 21 5121 5107
Email
info@shahed.ac.ir
Web page address
http://site.shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Jadid-Milani
Position
PhD of Nursing, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Faculty of Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini.Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
0098 21 6641 51212130
Fax
Email
milani@shahed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Jadid-Milani
Position
PhD of Nursing, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Faculty of Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2130
Fax
Email
milani2000ir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Jadid-Milani
Position
PhD of Nursing, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Nursing Faculty of Shahed University, Persian Gulf Highway (beginning of Tehran-Qom highway), Opposite to Holy Shrine of Imam Khomeini, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2130
Fax
Email
milani2000ir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is possible to use only the data of the main outcome of the study
From where data/document is obtainable
Maryam jadid-Milani
Shahed University, Nursing Department
milani2000ir@yahoo.com
00982151212130
What processes are involved for a request to access data/document
The initial permission must be obtained from the research assistance of Shahid University, and then the researcher will give the requested information to the applicant.