NCT06234865

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 15, 2024

Last Update Submit

February 13, 2024

Conditions

Keywords

constipationnursingorthopedic

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Constipation Education Questionnaire

    1 month

  • Use of constipation prevention methods

    1 month

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Control Group

Video Education Group

EXPERIMENTAL

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

Other: Video Education Group

Interventions

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.

Control 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.

Video Education Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur State Hospital

Burdur, 15100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 21637085BACKGROUND
  • 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

    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.

    PMID: 9299672BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sinan Aydoğan, Ph.D.

    Burdur Mehmet Akif Ersoy University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinan Aydoğan, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 31, 2024

Study Start

February 8, 2024

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations