Technology-based Constipation Prevention Training

February 13, 2024 updated by: Sinan Aydoğan, Mehmet Akif Ersoy University

The Effect of Technology-based Constipation Prevention Training on Constipation Management in Hospitalised Orthopaedic Patients

The aim of this study is to determine the effect of technology-assisted constipation prevention training on the management of constipation in hospitalised orthopaedic patients. 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 is planned to consist of patients over 18 years of age, who are able to communicate, who do not have sensory loss related to advanced vision and hearing, who do not have psychiatric disorders at a level that prevents communication, and who are hospitalised at the Orthopaedic Clinic and who volunteer to participate in the research. Data for the study will be collected using the "Patient Introduction Form", "Constipation Risk Assessment Scale (CRAS)", "Bristol Stool Consistency Scale", "Use of Constipation Prevention Methods Form", "Constipation Education Questionnaire", "Constipation Severity Scale". 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 hospitalised in the Orthopaedic Clinic. The data will be collected at 3 times: (1) before the training, (2) 2 weeks after the training, (3) 4 weeks after the training. The data will be digitalised in the SPSS 23 package and the necessary statistical analyses will be performed.

Study Overview

Status

Recruiting

Conditions

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

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Burdur, Turkey, 15100
        • Recruiting
        • Burdur State Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.
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.

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.
1 month
Costipation Severity Scale
Time Frame: 1 month
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constipation Education Questionnaire
Time Frame: 1 month
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.
1 month
Use of constipation prevention methods
Time Frame: 1 month
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sinan Aydoğan, Ph.D., Burdur Mehmet Akif Ersoy University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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