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CompletedNCT05308693Updated Jul 24, 2023

Evaluation of the Effect of Two Different Methods on Stoma Compliance and Self-efficacy

An interventional study of Education material - Patient Compatible Stoma Educational Material in Patient Relations, Nurse and Patient Satisfaction, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Acibadem University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Aug 2021, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

In patients with stoma, apart from traditional methods, different methods whşch can be used in visual, auditory and motor skills are recommended as a part of education methods regarding stoma care.

The aim of this study is to evaluate the effects of two different methods in teaching stoma care skills considering patients with colostomy/ileostomy on stoma compliance and self-efficacy levels. This research is the thesis study designed within the scope of the Surgical Diseases Nursing Master's program.

Read the detailed description

Stoma is the opening of the intestine to the abdominal wall. In recent years, the number of individuals with ostomy has been increasing, and it is stated that there are 800,000 individuals in North America alone and approximately 15,000 in Hong Kong.. As a result of this surgical procedure, regardless of ileostomy or colostomy, the daily life of individuals who went through this procedure has been affected in terms of not only the way their bodies excretes but also way of their eating habits, sexual life, self-esteem, religious/cultural needs, social life, sense of independence, self-care and the rest of their daily life.. Gaining patients' self-care activities related to stoma care begins in the preoperative period.

The self-care and development of activities in patients with stoma consists of cognitive, emotional, and psychomotor learning processes.

Patients need to acquire the necessary knowledge and skills to meet their new care needs. This learning process is based on the nurse's practical experience and teaching methods.. After the surgery of individuals with stoma; these individuals need training and counseling in order to manage the stoma functionally and to adapt a life with a stoma in psychological terms. Wound ostomy incontinence nurses; are an unique source of information when it comes to educating the individuals who have stoma.. The American Society of Colon and Rectal Surgeons recommends preoperative stoma training. In the post-operative period after a proper training given to individuals with stoma; It is stated that reduces stoma-related complications, shortens hospital stay, and reduces the cost of stoma care. In the literature, it is stated that the stoma training performed before the surgery shortens the discharge time, reduces the cost and improves the adequacy of the individuals.. The environment, duration, patient's readiness level, past knowledge and experience of patient, education method to be used, education content and material have an important place in patient training. The language of instruction should be plain and simple.. Today, in patient training, verbal information is provided by giving written materials or showing the care practices on the patient after the surgery. While increasing the permanence and effectiveness of the materials used with the developing technology, educational content such as brochures, models, booklets, question-answers, videos and slides also provide good results. However, since the socio demographic characteristics and learning styles of the patients are different from each other, the desired permanence may not be fully achieved. Since stoma care is frequently encountered in nursing practices, is of vital importance, and affects the quality of health care of the individual, family and society, overall it is expected that the permanence of education in this practice will be increased using audio-visual and motor skills, behavior change and self-efficacy will be improved considering the increasing compliance situation in patients with stoma.. Pouresmail et al. (2019) shows that the use of simulation to learn ostomy self-care improves self-efficacy in patients.. In the literature, studies on the subject are limited, and the aim of this study is to determine the effects of two different methods in stoma care education on stoma compliance and self-efficacy levels of patient

02

Conditions studied

  • Patient Relations, Nurse
  • Patient Satisfaction

Keywords

  • Stoma Adaptation
  • Self efficacy
  • Stoma Care education
03

In context

Lead sponsor

Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients aged 18-85 years
  • Patients who have a colostomy or ileostomy for any reason (cancer, ulcerative colitis, chron, hernia, etc.)
  • Patients who can speak and understand Turkish and do not have a psychological or neurological disease (Advanced Parkinson's, Alzheimer's, Depression, etc.)

Exclusion criteria

Exclusion Criteria:

  • Patients with visual and hearing impairment
  • Patients that are unable to use their hands and upper extremities (hemiplegic, paraplegic, etc.)
  • Patients who requires a revision surgery after surgery
  • Patients whose temporary stoma was closed while in the data collection process
  • Patients with postoperative complications and prolonged discharge period (evisceration, bleeding, perforation, etc.) will be excluded from the sample.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • No intervention
    Control-Classical patient education

    Before the operation, the stoma area is marked, the patient is educated with the classical method brochure

  • Experimental
    Experimental-Patient Compatible Stoma Educational Material

    The stoma area is marked before the operation; A brochure is given to the patient. Practical training is given on the patient's own body with patient-compatible stoma training material.

    Other: Education material - Patient Compatible Stoma Educational Material

Interventions

  • OtherEducation material - Patient Compatible Stoma Educational Material

    It is an educational material made of rubber, similar to a stoma, that can be placed on the patient.

06

What researchers measure

Primary outcomes

  1. State Anxiety Level

    State Anxiety Level is evaluated by Spielberger State-Trait Anxiety Inventory - This inventory is a four-degree Likert type scale ranging from "Almost never" to "Almost always". In the state anxiety scale, the individual evaluates how he/ she feels "right now". The total score obtained from each scale varies between 20 and 80. A high score indicates a high anxiety level, a low score indicates a low anxiety level

    Time frame: after surgery, post-operative 1. day (first stoma care)

Secondary outcomes

  1. Stoma Self-Efficacy Scale

    In order to determine the self-efficacy levels of individuals with stoma, the psychometric properties of the scale were examined in English, Knippenberg, Van Berge-Henegouwen in 1996. Turkish validity and reliability of the scale Karaçay et al. Adapted by (2020). The scale consists of 22 items. The scale, which is graded in a five-point Likert type, consists of two sub-dimensions. Sub-dimensions; Stoma Care is Self-Efficacy and Social Self-Efficac. The possible score on the scale ranges from 22 to 110. The higher the score, the better the level of self-efficacy

    Time frame: The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone

Other outcomes

  1. Adjustment Scale for Individuals with Ostomy

    It is a self-assessment scale consisting of 23 items developed by Simmsons, Smith, and Maekawa to determine the compliance of individuals with stoma. Adjustment Scale for Individuals with Ostomy Karadağ et al. (2011), adapted into Turkish. The scale, which is graded in a five-point Likert type, has four sub-dimensions. These four dimensions are anger, social adaptation, anxiety/worry and acceptance. While the lowest score on the scale is '0', the highest score is '92'.

    Time frame: The scale is filled in 3 times; 3 days after the surgery (post-operative 3. day) in hospital (1), and at the 3rd week after surgery (post-operative 21. day) at home by telephone (2) and 9th week after surgery (post-operative 63. day) (3) at home by phone

07

Study locations

1 site
  • Yasemin Uslu
    İstanbul, Ataşehir 34752, Turkey
08

References and documents

Publications

  • Karacay P, Togluk Yigitoglu E, Karadag A. The validity and reliability of the Stoma Self-Efficacy Scale: A methodological study. Int J Nurs Pract. 2020 Dec;26(6):e12840. doi: 10.1111/ijn.12840. Epub 2020 Apr 17. PubMed 32301580 ↗
  • Stelton S. CE: Stoma and Peristomal Skin Care: A Clinical Review. Am J Nurs. 2019 Jun;119(6):38-45. doi: 10.1097/01.NAJ.0000559781.86311.64. PubMed 31135430 ↗
  • Giordano V, Nicolotti M, Corvese F, Vellone E, Alvaro R, Villa G. Describing self-care and its associated variables in ostomy patients. J Adv Nurs. 2020 Nov;76(11):2982-2992. doi: 10.1111/jan.14499. Epub 2020 Aug 26. PubMed 32844474 ↗
  • Seo HW. Effects of the frequency of ostomy management reinforcement education on self-care knowledge, self-efficacy, and ability of stoma appliance change among Korean hospitalised ostomates. Int Wound J. 2019 Mar;16 Suppl 1(Suppl 1):21-28. doi: 10.1111/iwj.13047. PubMed 30793857 ↗
  • Zhang Y, Xian H, Yang Y, Zhang X, Wang X. Relationship between psychosocial adaptation and health-related quality of life of patients with stoma: A descriptive, cross-sectional study. J Clin Nurs. 2019 Aug;28(15-16):2880-2888. doi: 10.1111/jocn.14876. Epub 2019 May 5. PubMed 30939212 ↗
  • Cheng F, Meng AF, Yang LF, Zhang YN. The correlation between ostomy knowledge and self-care ability with psychosocial adjustment in Chinese patients with a permanent colostomy: a descriptive study . Ostomy Wound Manage. 2013 Jul;59(7):35-8. PubMed 23846005 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05308693
Lead sponsor
Acibadem University
Responsible party
Acibadem University (Asisst. Prof., Acibadem University) — Principal investigator
First posted
Apr 4, 2022
Start date
Aug 1, 2021
Primary completion
Jun 19, 2023
Completion
Jun 19, 2023
Last update
Jul 24, 2023

Study contacts

Yasemin Uslu, Asisst.Prof
study director · Acıbadem Mehmet Ali Aydınlar Üniversitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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