Technology-based Constipation Prevention Training

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234865
• Other study ID #: MehmetAkifU-SBF-SA-1
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2024
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Mehmet Akif Ersoy University
• Contact: Sinan Aydogan, Ph.D.
• Phone: 02482133564
• Email: saydogan[@]mehmetakif.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• Control Group
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.
• Video Education Group
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.

Locations

Country	Name	City	State
Turkey	Burdur State Hospital	Burdur

Sponsors (1)

Lead Sponsor	Collaborator
Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Kaya, N. ve Turan, N. (2011). Konstipasyon Ciddiyet Ölçeginin güvenilirlik ve geçerliligi. Türkiye Klinikleri Journal of Medical Sciences, 31(6), 1491- 1501. doi: 10.5336/medsci.2010-22198

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bristol Stool Consistency Scale	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
Primary	Costipation Severity Scale	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	Constipation Education Questionnaire	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
Secondary	Use of constipation prevention methods	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