- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06234865
Technology-based Constipation Prevention Training
The Effect of Technology-based Constipation Prevention Training on Constipation Management in Hospitalised Orthopaedic Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: The aim of this study is to determine the effect of technology-assisted constipation prevention training on constipation management for patients admitted to an orthopaedic clinic.
Method This is a quasi-experimental study. The population of the study will consist of patients admitted to the Orthopaedic Clinic of Burdur State Hospital between January 2024 and November 2024. The sample of the study will consist of patients over the age of 18, who are able to communicate, who do not have advanced sensory loss related to vision and hearing, who do not have psychiatric disorders at a level that prevents communication, and who are admitted to the Orthopaedic Clinic and volunteer to participate in the study.
The study population consisted of patients admitted to the orthopaedic service. To calculate the sample size, an α error of 0.05 and a power of 0.95 were set using G power 3.1 software, based on previous studies with a similar design. As a result, a total of 70 patients were needed for this study after accounting for a 10% drop-out rate.
Data collection The data of the study will be collected by "Patient Introduction Form", "Constipation Risk Assessment Scale (CRAS)", "Bristol Stool Consistency Scale", "Use of Constipation Prevention Methods Form", "Constipation Education Questionnaire", "Constipation Severity Scale".
The "Patient Introduction Form", "Use of Constipation Prevention Methods Form" and "Constipation Education Questionnaire" will be prepared by the researchers according to the information in the literature.
Implementation of the research During the implementation of the research, it is planned to form two groups, the first 35 patients in the control group and the second 35 patients in the experimental group, from the patients admitted to the Orthopaedic Clinic.
The 'Patient Introduction Form', 'Constipation Risk Assessment Scale (CRAS)', 'Bristol Stool Consistency Scale' and 'Constipation Severity Scale' will be used for the patients in the control group. The Bristol Stool Consistency Scale will be given to patients to facilitate telephone follow-up. Patients' constipation management will be assessed twice, two weeks and one month after the interview day. The Bristol Stool Consistency Scale, the Use of Constipation Prevention Methods Form and the Constipation Severity Scale will be completed. A constipation prevention booklet is given by the nurses as part of routine clinic care.
The ''Patient Introduction Form'', ''Constipation Risk Assessment Scale (CRAS)'', ''Bristol Stool Consistency Scale'' and ''Constipation Severity Scale'' will be applied to the patients in the experimental group. Unlike the control group, the patient will be asked to watch an educational video about constipation using a tablet. In addition, the patient will be given a constipation education booklet. A 'Constipation Education Question Form' will be completed after the training. The Bristol Stool Consistency Scale will be given to patients to facilitate telephone follow-up. As in the control group, the patients' constipation management will be evaluated twice, two weeks and one month after the day of the patient interview. The Bristol Stool Consistency Scale, the Visual Comparison Scale, the Use of Constipation Prevention Methods Form and the Constipation Severity Scale will be completed. Routine care is provided by nurses in the clinic.
Analyzing the Data The data will be digitalised in the SPSS 23 package and the necessary statistical analyses will be performed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sinan Aydoğan, Ph.D.
- Phone Number: 02482133564
- Email: saydogan@mehmetakif.edu.tr
Study Locations
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-
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Burdur, Turkey, 15100
- Recruiting
- Burdur State Hospital
-
Contact:
- Aysenur Aydogan, Bachelor
- Phone Number: +905456154485
- Email: aysenurdag26@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be over 18 years of age
- be hospitalised at the Orthopaedic Clinic
- to be able to read and write
- be willing to participate in the research
- having a moderate or high risk of constipation according to the Constipation Risk Assessment Scale (CRAS) or being constipated
Exclusion Criteria:
- has bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, hernia and bowel cancer
- has a psychiatric disorder at a level that prevents communication
- Difficulty in understanding and speaking Turkish
- Severe sensory loss related to vision and hearing
- Having a colostomy or ileostomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
Patients in the control group will receive the routine care of the orthopaedic clinic and education with a brochure about preventing constipation.
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Patients in the control group will receive standard education plus a brochure education.
Standard education includes education provided by the doctor, nurse and/or physiotherapist before and after surgery.
The brochure education includes information about constipation and interventions that can be used to prevent constipation such as nutrition, fluid intake, physical activity, leg exercises, abdominal massage, and toilet habits.
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Experimental: Video Education Group
Patient in the experimental group will receive the routine care of the orthopaedic clinic and a video education about preventing constipation.
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Patients in the experimental group will receive standard education plus a video education.
Standard education includes education provided by the doctor, nurse and/or physiotherapist before and after surgery.
The video education includes information about constipation and interventions that can be used to prevent constipation such as nutrition, fluid intake, physical activity, leg exercises, abdominal massage, and toilet habits.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bristol Stool Consistency Scale
Time Frame: 1 month
|
The Bristol Stool Consistency Scale was developed by Lewis and Heaton (1997) at the University of Bristol in the United Kingdom and is based on the visualisation of seven stool shapes to determine stool consistency.
According to the Bristol Stool Consistency Scale, type 1 and type 2 indicate constipation, type 3 and type 4 indicate normal stools, and type 5, type 6 and type 7 indicate diarrhoea.
It is recognised that there is a direct relationship between the shape of the stool and the length of time it remains in the colon.
The form has been designed to enable patients to visually identify the consistency of stool at each defecation.
It can be used with illiterate patients.
The form is completed by the researcher face-to-face with the patient during the application process.
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1 month
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Costipation Severity Scale
Time Frame: 1 month
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The Turkish validity and reliability of the CSS, which was developed by Varma et al. in 2008, was conducted by Kaya and Turan (2010).The CSS is a scale to determine the frequency, intensity, and difficulty of defecation.
This scale was also designed to measure constipation symptoms.
The scale consists of 16 questions.
The CSS has three sub-dimensions: Bowel Obstruction, Colon Laziness and Pain.
The score that can be obtained from the Faecal Obstruction sub-dimension is 0-28, the score that can be obtained from the Constipation sub-dimension is 0-29, and the score that can be obtained from the Pain sub-dimension is 0-16.
The lowest total score that can be obtained from the CSS is 0 and the highest score is 73.
The high score obtained from the scale indicates that the symptoms are severe.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Constipation Education Questionnaire
Time Frame: 1 month
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This form, developed by the researchers, contains a total of 5 questions to measure the patient's level of understanding and satisfaction with the education provided.
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1 month
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Use of constipation prevention methods
Time Frame: 1 month
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This investigator-developed form included 6 questions about the patients' diet, fluid intake, whether they used abdominal massage, leg exercises, physical activity, and whether they delayed bowel movements.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sinan Aydoğan, Ph.D., Burdur Mehmet Akif Ersoy University
Publications and helpful links
General Publications
- Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
- Kutlu AK, Yilmaz E, Cecen D, Eser E. The reliability and validity of the Turkish version of the constipation risk assessment scale. Gastroenterol Nurs. 2011 May-Jun;34(3):200-8. doi: 10.1097/SGA.0b013e31821ab553.
- Kaya, N. ve Turan, N. (2011). Konstipasyon Ciddiyet Ölçeğinin güvenilirlik ve geçerliliği. Türkiye Klinikleri Journal of Medical Sciences, 31(6), 1491- 1501. doi: 10.5336/medsci.2010-22198
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MehmetAkifU-SBF-SA-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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