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IRCT20201023049119N1 IRCT 2021-04-10 Bojnourd University of Medical Sciences The effect of using Salvadora Persica toothbrush on elderly constipation intensity The effect of using Salvadora Persica toothbrush on the intensity of constipation in the elderly referred to specialized gastroenterology clinic. 2021-03-05 anticipated 60 Complete https://irct.ir/trial/51844 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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, 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. N/A Constipation. Intervention 1: 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 . Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information is available for now.
public Raheleh Yousefzadeh
Plaque12. Alley 30. South Danesh
Gonbad-e Qabus Iran (Islamic Republic of) 4971889711 +98 17 2238 6734 susfzd76@gmail.com Bojnourd University of Medical Sciences scientific Raheleh Yousefzadeh
Plaque12. Alley 30. South Danesh
Gonbad-e Qabus Iran (Islamic Republic of) 4971889711 +98 17 2238 6734 susfzd76@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) 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. 60 years no limit Both Being on treatment for heart disease, hypertension, respiratory diseases and gastrointestinal ulcers. Being addicted to drugs. Use of medications causing constipation. K59.00 Constipation, unspecified Treatment - Drugs Treatment - Devices 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 . 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. 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. Bojnourd University of Medical Sciences Approved 2021-02-01 Ethics committee of North Khorasan University of Medical Sciences Central Library. School of Medicine. south side of the hospital. Shahriar St. Bojnourd. Bojnurd North Khorasan Iran (Islamic Republic of)