Web-Assisted Interactive Nurse Program in Mastectomy Patients: A Mixed Method Study

NCT ID: NCT05222763

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-24
• Study Completion Date: 2023-08-29

Brief Summary

This study is planned to examine the levels of bodily value, care dependence and psychosocial cohesion-self-notification of patients in the Web Assisted Interactive Nursing Program (WDIHP) designed according to the Self Regulation Model. The mixed method is a research. One of the mixed research methods, the discovery sequenced design, will be used. The research will continue with the quantitative part, starting with the qualitative part. The quantitative part of the research is a randomized controlled experimental trial.

Detailed Description

Complications after surgery are common in patients who undergo mastectomies, as in every surgery. Mastectomy patients need to protect the wound area and the arm on the side where a mastectomy is performed following surgery. The process of wound healing and return to the patient's daily life in the post-surgery process parallels. In the early post-operative period, patients have difficulty carrying out daily living activities and need support, while in the late-term they are able to perform daily living activities more independently from caregivers and nurses.

Objective: This research was planned to examine the body value of mastectomy patients, care dependence and psychosocial adaptation-self-knowledge levels of the Web Assisted Interactive Nursing Program (WDIHP) designed according to the Self-Regulation Model.

Method: The research is designed as a mixed-method study of qualitative-quantitative research methods, designed according to the Self-Regulation Model, to examine the effect of WDHP on adaptation to social life, self-efficacy, and body value in patients undergoing breast cancer surgery. This study will use exploratory hybrid methods from mixed research methods. Qualitative interviews will be held face-to-face. Interviews with participants will continue until data saturation is achieved. In the qualitative part of the research, the in-depth interview method will be selected and the "Semi-Structured Interview Form" will be used as a data collection tool. All interviews will be recorded in digital format, returned to writing and then transferred to qualitative analysis software MAXQDA. The quantitative part of the study will be carried out as a randomized controlled trial using the block randomization method. Randomization will be done by a statistician other than the researcher. Power analysis was calculated using G * Power 3.1.9.7 program. With 0.95 effect size, 95% power and 0.05 significance level, the required sample size was determined as 30 individuals per group, and 60 individuals in total. It was decided to include 67 individuals, 35 individuals in the intervention group and 31 individuals in the control group, by taking 15% more of the calculated sample against the possibility of sample loss during the study. The correct perceptions that may arise as a result of qualitative work will be supported in the relevant sections of the training. In the quantitative section of the research, the interactive web-assisted nurse program will take 1 week and the application will take 3 weeks. A text message will be sent to individuals to their phone to remind them to use the website. Messages will be sent twice a week, a total of 8 times. It will be used as Care Dependency, Body value, psychosocial Compliance to disease, website usability Scale measurement tools. After each assessment, the data obtained will be transferred to the "Social Sciences Software Statistical Package (SPSS).

Conditions

Web Based Intervention; Mastectomy; Illness Perception; Nursing Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Interventional group

The web-supported interactive nursing program intervention will take 3 weeks. The first week of the training will begin with the patient's admission to the clinic. Shoulder and Arm Exercises, Lymphedema in the Arm and Prevention of Its Development, and qualitative study, the themes of misperception determined in this area will be emphasized. In the second week, they will be asked to continue their Shoulder and Arm Exercises training, to examine the Other Side Breast Examination Training and Adaptation Process to Life Activities, Skin Care and Post-Surgery Cancer Treatment and Breast Reconstruction. In the last week of the training, it will be requested to review the contents again. Correct perceptions that may emerge as a result of the qualitative study will be supported in the relevant parts of the training. During the study, short mobile phone messages containing reminders and motivations will be sent regularly twice a week (8 times).

Group Type: EXPERIMENTAL

Web-assisted patient education intervention designed according to the self-regulation model

Intervention Type: BEHAVIORAL

Implementation of patient education with the website created about care and compliance needs in mastectomy patients obtained as a result of qualitative research.

Behavioral:

The handbook developed within the scope of the "Women's Return to Social Life After Mastectomy" Project on the website of the Continuing Education, Research and Solidarity Association will be used on the website of the participants assigned to the control group.

Group Type: ACTIVE_COMPARATOR

The website where the mastectomy patients handbook

Intervention Type: BEHAVIORAL

The site where the patient booklet is available as pdf

Interventions

Web-assisted patient education intervention designed according to the self-regulation model

Implementation of patient education with the website created about care and compliance needs in mastectomy patients obtained as a result of qualitative research.

Intervention Type: BEHAVIORAL

The website where the mastectomy patients handbook

The site where the patient booklet is available as pdf

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients aged 18-75 who do not have communication problems,
• Patients who have undergone mastectomy for the first time,
• Patients who know their diagnosis,
• Patients with basic computer literacy,
• Patients with computer or internet access.
• Patients who agree to participate in the study will be included.

Exclusion Criteria

• Patients with hearing, vision and understanding problems,
• Patients with metastases
• Patients with breast cyst excision,
• Patients with arm or shoulder limitation,
• Patients with breast reconstruction will not be included in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Şeyda KAZANÇ

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Şeyda KAZANÇ, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Şerife KARAGÖZOĞLU, Prof. Dr.

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Gaziosmanpasa University

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

939597

Identifier Type: -

Identifier Source: org_study_id