Clinical trial NCT06234865: Technology-based Constipation Prevention Training
Official title: The Effect of Technology-based Constipation Prevention Training on Constipation Management in Hospitalised Orthopaedic Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation
Keywords: constipation
nursing
orthopedic
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bristol Stool Consistency Scale
timeFrame: 1 month
measure: Costipation Severity Scale
timeFrame: 1 month
Secondary outcomes:
measure: Constipation Education Questionnaire
timeFrame: 1 month
measure: Use of constipation prevention methods
timeFrame: 1 month
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur State Hospital
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Sinan Aydoğan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.