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The effect of using Salvadora Persica toothbrush on the intensity of constipation in the elderly referred to specialized gastroenterology clinic.

Protocol summary

Study aim
To determine the effect of using Salvadora Persica toothbrush on intensity of constipation in elderly referred to Golestan Gastroenterology Clinic
Design
Randomized trial with two parallel groups on 60 elderly, no blinding, using computer software to generate random codes in form of permuted blocks.
Settings and conduct
Elderly people who refer to the gastroenterology clinic and are eligible for study will be allocated to control and intervention groups based on random codes. After receiving necessary instruction, participants in the intervention and control groups will use the Salvadora Persica toothbrush, and regular toothbrush, respectively. Constipation intensity will be evaluated at study onset, week 3, and week 6.
Participants/Inclusion and exclusion criteria
Being over 60 years old. Being fully conscious and teachable. Having natural teeth and degrees of constipation. Being a city resident. Being able to perform the intervention protocol independently or with the help of their caregiver. Using C-Lax pill for their constipation. Not using narcotics or medications such as iron tablets or calcium, that cause constipation.
Intervention groups
In the intervention group, participants after receiving necessary instruction will use Salvadora Persica toothbrush 3 times a day, at morning, noon, and night, 5 minutes each time, for 6 weeks. In control group, participants will use their regular toothbrush 3 times a day, at morning, noon, and night, 5 minutes each time, for 6 weeks.
Main outcome variables
Constipation intensity will be assessed using the Constipation Assessment Scale (CAS) and with the scores ranging from 0 to 16; with higher scores denote more severe constipation. Measurements will be done at study onset, week 3, and week 6. Also, to increase the validity of data the Bristol Stool Scale (BSS) that evaluates the stool appearance will be used during the study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201023049119N1
Registration date: 2021-04-10, 1400/01/21
Registration timing: registered_while_recruiting

Last update: 2021-04-10, 1400/01/21
Update count: 0
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
Raheleh Yousefzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3328 6734
Email address
r.yousefzadeh@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using Salvadora Persica toothbrush on the intensity of constipation in the elderly referred to specialized gastroenterology clinic.
Public title
The effect of using Salvadora Persica toothbrush on elderly constipation intensity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 60 years old. Being fully conscious and teachable. Having natural teeth. Having degrees of constipation (too mild to severe). Being a city resident. Being able to perform the intervention protocol independently or with the help of their caregiver. Being able to do activities of daily living. Using C-Lax pill for their constipation.
Exclusion criteria:
Being on treatment for heart disease, hypertension, respiratory diseases and gastrointestinal ulcers. Being addicted to drugs. Use of medications causing constipation.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
First, a purposive sampling will be done; then eligible subjects will be randomly allocated into two groups, using permutation blocks randomization approach and the codes generated by the relevant software. Subjects will be randomized individually.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this trial, participants in control group will use a regular plastic toothbrush, and in intervention group will use Salvadora Persica toothbrush 3 times a day, at morning, noon, and night, 5 minutes each time, for 6 weeks. Participants will receive information on how to use toothbrushes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
Central Library. School of Medicine. south side of the hospital. Shahriar St. Bojnourd.
City
Bojnurd
Province
North Khorasan
Postal code
9414974877
Approval date
2021-02-01, 1399/11/13
Ethics committee reference number
IR.NKUMS.REC.1399.126

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
K59.00
ICD-10 code description
Constipation, unspecified

Primary outcomes

1

Description
Constipation intensity based on the score of Constipation Assessment Scale (CAS).
Timepoint
Study onset (before starting the intervention), week 3, and week 6 after starting the intervention.
Method of measurement
Using of Constipation Assessment Scale: This questionnaire was published by McMillan in 2001 and contains 8 questions; each question has three answer options with scores from zero to 2; Total score ranges from zero to 16, with the higher score denotes more severe constipation.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: participants in this group will use their regular plastic toothbrush 3 times a day, at morning after breakfast, noon after lunch, and night after dinner, 5 minutes each time, for 6 weeks. Participants will receive necessary instruction on appropriate use of the toothbrush .
Category
Treatment - Drugs

2

Description
Intervention group: participants in this group will use Salvadora Persica wood as toothbrush. Participants and their caregivers will receive instructions on how to prepare, use, and maintain this toothbrush by description and showing video. Participants will use the toothbrush 3 times a day, at morning after breakfast, noon after lunch, and evening after dinner, 5 minutes each time, perpendicular to teeth and gums with rotating movements. Before using, the toothbrush is placed in tepid water to soften the fibers, and then about 1 cm of the stem skin is peeled and the fibers inside are unbraided using a hammer or with teeth. The toothbrush is held like a pen in hand, rubbed on teeth and the gums. After finishing, the used part is cut and disposed. The toothbrush is washed and dried after each use to prevent contaminants. This protocol will be done for 6 weeks.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized gastrointestinal clinic
Full name of responsible person
Dr. Peyman Sanjari
Street address
3rd floor. Bozorgmehr Doctors Building. East Taleghani St.
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971889711
Phone
+98 17 3323 5835
Email
Dr.p.sanjari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Amir Amani
Street address
South side of Imam Ali Hospital. Shahriar Street. Bojnoord.
City
Bojnurd
Province
North Khorasan
Postal code
94176-96786
Phone
+98 58 3229 7182
Email
research@nkums.ac.ir
Web page address
http://nkums.ac.ir/index.aspx?Catid=508
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
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
Bojnourd University of Medical Sciences
Full name of responsible person
Raheleh Yousefzadeh
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Plaque12. Alley 30. South Danesh
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971889711
Phone
+98 17 2238 6734
Email
susfzd76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Raheleh Yousefzadeh
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Plaque12. Alley 30. South Danesh
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971889711
Phone
+98 17 2238 6734
Email
susfzd76@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Raheleh Yousefzadeh
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Plaque12. Alley 30. South Danesh
City
Gonbad-e Qabus
Province
Golestan
Postal code
4971889711
Phone
+98 17 2238 6734
Email
susfzd76@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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