Technology-based Constipation Prevention Training

NCT ID: NCT06234865

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2024-11-30

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.

Conditions

Constipation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patients in the control group will receive the routine care of the orthopaedic clinic and education with a brochure about preventing constipation.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

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

Patient in the experimental group will receive the routine care of the orthopaedic clinic and a video education about preventing constipation.

Group Type: EXPERIMENTAL

Video Education Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Sinan Aydoğan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sinan Aydoğan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Burdur State Hospital

Burdur, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sinan Aydoğan, Ph.D.

Role: CONTACT

saydogan@mehmetakif.edu.tr

02482133564

Facility Contacts

Aysenur Aydogan, Bachelor

Role: primary

aysenurdag26@gmail.com

+905456154485

References

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.

Reference Type: BACKGROUND

PMID: 21637085 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 9299672 (View on PubMed)

Other Identifiers

MehmetAkifU-SBF-SA-1

Identifier Type: -

Identifier Source: org_study_id