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

Patient Satisfaction Clinical Trial

Official title:

Evaluation of the Effect of Two Different Methods in Teaching Stoma Care Skills in Patients With Stoma on Stoma Compliance and Self-efficacy Level of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308693
• Other study ID #: ATADEK 2021-13/04
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 19, 2023

Study information

• Verified date: July 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 19, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Patient Relations, Nurse
• Patient Satisfaction

Intervention

Other:
• Education 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.

Locations

Country	Name	City	State
Turkey	Yasemin Uslu	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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/i — View Citation

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. — View Citation

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 Karadag 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'.	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
Primary	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	after surgery, post-operative 1. day (first stoma care)
Secondary	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	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