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The Effect of Education and Counseling Given to People With Stoma by Telephone on Stoma Compliance and Complications

Ç

Çukurova University

Status

Completed

Conditions

Stoma Colostomy

Treatments

Other: Education and counseling intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06189300
5077606250

Details and patient eligibility

About

The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size was found to be high, and the statistical power of the study was calculated as 2.955. Therefore, the power level was set at 0.80. The sample size for each group was calculated as 30 using the G*Power 3.1.9.7 program with an effect size of 0.8, 5% margin of error and 80% power %. Considering the possibility of data loss, the number of samples for each group was increased by 20% and it was planned to include 36 patients for each group. The Ostomy Adjustment Inventory and Pittman Ostomy Complication Severity Index will be completed. The scales will be collected for both groups on the first day, first month, and third month postoperatively. Patients were contacted five times postoperatively to provide education and counseling. SPSS will be used for data analysis.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Having undergone stoma surgery in a university hospital,
  • No vision or hearing problems,
  • Verbal communication is possible,
  • Without diagnosed psychiatric problems.

Exclusion criteria

  • Want to leave the research

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

66 participants in 2 patient groups

Telephone Education
Experimental group
Description:
Training and consultancy will be provided
Treatment:
Other: Education and counseling intervention
Control
No Intervention group
Description:
Standard care will be given

Trial contacts and locations

1

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Central trial contact

Seyma Yurtseven, Dr.

Data sourced from clinicaltrials.gov

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