The Effect of Guided Imagery Based on the Health Promotion Model on the Quality of Life in Breast Cancer Patients

NCT05484180 | Completed

• 1 other identifier: Glnz87?
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a randomized controlled double-blind experimental study aiming to evaluate the effect of guided imagery based on the health promotion model in breast cancer patients on healthy lifestyle behaviors and quality of life. Research; It will be carried out between January-September 2022 with patients diagnosed with breast cancer who have completed the treatment process and registered in the Medical Oncology Polyclinic of Ataturk University Health Research and Application Center. The sample of the study will consist of 70 people, 34 of which are in the experimental group and 34 in the control group. After obtaining verbal and written consents from all sampled individuals, respectively; Introductory Information Form, Healthy Lifestyle Behaviors Scale II, SF-36 Quality of Life Scale and Body Mass Index Assessment will be applied as pre-test. Then, as a nursing attempt to the individuals in the experimental group; Training and consultancy supported guided imagery based on the health promotion model will be implemented. This initiative; It will take a total of 12 weeks, including 6 weeks of training program and 6 weeks of counseling program and guided imagery. After the application is completed, post-test measurements of the patients in the experimental and control groups will be made. For final test measurements; Healthy Lifestyle Behaviors Scale II, SF-36 Quality of Life Scale and Body Mass Index Assessment will be performed; Feedback will be received from the patients in the experimental group regarding the research process. No attempt will be made to the individuals in the control group during the research process, and after the research process is over, the same intervention applied to the experimental group will be applied to the control group. Then, the feedback of the individuals in the control group regarding the research process will be received. The data obtained in the research will be evaluated in the SPSS 22.00 package program. Ethical principles will be followed at all stages of the research, for which ethics committee approval has been obtained, and the Helsinki Declaration of Human Rights will be adhered to. It is planned to present the results of the research at an international congress and to be published in a journal within the scope of SCI/SSCI, to be brought to the scientific literature and announced. Keywords: Breast Cancer, Guided Imagery, Health Behaviors, Health Promotion Model, Nursing, Quality of Life

Conditions

Breast Cancer Female

Keywords

Guided Imagery; Breast Cancer; Nursing; Quality of Life; Healthy Lifestyle Behaviors

Outcome Measures

Primary Outcomes (4)

• The sociodemographic characteristics of the participants and their homogeneous distribution according to the experimental and control groups

  The sociodemographic characteristics of the participants and their homogeneous distribution according to the experimental and control groups will be evaluated with the introductory information form. Introductory Information Form: Developed by researchers in line with the literature and prepared by taking the opinions of four experts; It includes 10 questions such as age, education level, family type, marital status, number of children, monthly income, occupation, time of diagnosis of the disease, clinical stage of diagnosis and completed treatments.

  baseline

• The healthy lifestyle behaviors

  The healthy lifestyle behaviors of the participants will be evaluated with the Healthy Lifestyle Behaviors Scale II. The scale consists of 52 items and six sub-dimensions. The sub-dimensions of HLBD are as follows: Spiritual development, health responsibility, physical activity, nutrition, interpersonal relationships and stress management. All questions related to HLPV are weighted on a four-point Likert-type scale as never (1), sometimes (2), often (3), regularly (4). The lowest score for the whole scale is 52, and the highest score is 208.

  12 weeks

• Participants' quality of life level

  The quality of life of the participants will be evaluated with the SF-36 Quality of Life Scale. The quality of life scale; It contains 36 statements that evaluate 2 main dimensions and 8 sub-dimensions. The scale has likert type scoring. 35 out of 36 statements in the scale are evaluated considering the last 4 weeks. "How do you find your current health when compared to a year ago?" which includes the perception of change in health in the last 12 months in the scale. statement is not taken into account in the evaluation. The scale does not have a single total score, and the score for each dimension is calculated separately. The scores of each sub-dimension and the two main dimensions range from 0 to 100. The positive scoring SF-36, the higher the score of each dimension; Health-related quality of life was scored as increased.

  12 weeks

• Body Mass Index (BMI) Evaluation

  BMI; In the research, it will be evaluated by the interviewer twice, in the pre-test and post-test. BMI will be calculated by measuring height and weight with scales and tape measure at the participants' homes. Height and weight measurements will be made for the pre-test and post-test at the same time of the day, wearing the same clothes and taking into account the same hunger / satiety conditions. After the height and weight measurements of the participants are made, the BMI calculation will be made on the official website of the Ministry of Health. BMI; If it is less than 18.50, it will be considered as underweight, between 18.50-24.99 as normal/healthy weight, between 25-29.99 as overweight/overweight, and above 30 as overweight/obese.

  12 weeks

Secondary Outcomes (1)

• Feedback Form Regarding the Research Process

  12 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

As a nursing initiative to the experimental group in the research; Training and consultancy supported guided imagery application based on the health promotion model was applied.

Other: training and counseling supported guided imagery application

control group

NO INTERVENTION

No attempt will be made on individuals in the control group during the research process. After the research process is over; After the training booklet, Mp3 player loaded with directed imagery recording and exercise materials are delivered, guided imagery application based on the Health Promotion Model will be supported by training and counseling.

Interventions

training and counseling supported guided imagery application OTHER

After the preparation process, as a nursing attempt to the individuals in the experimental group; Training and consultancy supported guided imagery based on the health promotion model will be implemented. This initiative; It will take a total of 12 weeks, including 6 weeks of training program and 6 weeks of counseling program and guided imagery.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed in stage I, II or III of breast cancer
• Without organ metastasis
• Those who have not been diagnosed with any other cancer other than breast cancer
• Literate
• Able to communicate verbally
• Capable of using a smartphone
• Internet connection and online access
• Those who have not practiced directed imagery before
• Declaring that they can apply the directed imagery technique

You may not qualify if:

• IV of breast cancer. diagnosed at stage
• Organ metastases
• Those who have been diagnosed with a cancer other than breast cancer
• illiterate
• Cannot communicate verbally
• Unable to use a smartphone
• No internet connection or online access
• Those who have practiced directed imagery before
• Individuals who declare that they cannot apply the directed imagery technique will be excluded from the sample.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Gülnaz Ata

Yakutiye, Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gülnaz Ata

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In the data collection process, double-blindness was provided by not specifying which group the interviewer was collecting data from and which group participants were in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomization was done with 68 people. Simple randomization method was used in order to assign 68 people included in the study to the experimental and control groups in an unbiased manner. For randomization, a sample pool of people included in the study was created. Randomization was done in computer environment using https://www.random.org/ website. The women in the experimental and control groups were determined according to the order obtained. In this way, 34 individuals were included in the experimental group and 34 individuals in the control group.

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 2, 2022
• Study Start: February 1, 2022
• Primary Completion: September 11, 2022
• Study Completion: November 15, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

TU (1)