Evaluation of the Effects of Using Cooling Pillowcases, on the Symptoms of Hot Flushes, Sleep and Life Quality

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06415162
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

This study was planned to evaluate the effect of education on the management of side effects and the use of cooling pillowcase on hot flush complaints, sleep and quality of life in women with breast cancer receiving hormone therapy.

Detailed Description

It is planned to apply pre-test evaluations in the 1st week and post-test evaluations in the 9th week to the intervention (training) group consisting of women with breast cancer who agree to participate in the study. A total of 3 follow-ups will be performed on the patients in the intervention (education) group in weeks 3 and 7 by telephone interview method and in week 5 by face-to-face interview method using the Patient Follow-up Form. In addition, in order to evaluate the effectiveness of the education given to the patients in the intervention (education) group, the Practices for Coping with the Side Effects of Hormone Therapy Form will be completed in the 5th and 9th weeks.

The control group consisting of women with breast cancer who agreed to participate in the study will be administered pre-test evaluations at week 1 and post-test evaluations at week 9. The patients in the control group will not be subjected to any intervention by the researcher, their routine treatment and care will continue, and they will be followed up only once in the 5th week by phone call.

Study Timeline

• Study Start: 2023-12-19
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Last Update Submitted: 2024-05-10
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• 18 years of age or older,
• Estrogen and progesterone receptor positive, stage 1, 2, 3 or 4 primary breast cancer,
• Receiving hormone therapy (goserelin acetate subcutaneously every 4 weeks),
• Pre/Perimenopausal period,
• No sensory and emotional barriers to communication,
• Understands Turkish, can read and write,
• Patients who voluntarily agreed to participate in the study.

Exclusion Criteria

• Receiving treatment for anxiety and/or depression,
• Receiving gabapentin treatment for neuropathic pain,
• Active viral or bacterial infection,
• Patients with a history of sleep disorders diagnosed before hormone therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Menopausal Hot Flush Scale	nine weeks	All items in the scale are evaluated between '0' and '10' points. The highest score that can be obtained from the scale is '100' and the lowest score is '0'. The higher the score obtained from the scale, the higher the woman's level of being affected by hot flushes.

Secondary Outcome Measures

Name	Time	Method
Functional Assessment Of Cancer Therapy-Breast (FACT-B)	nine weeks	The responses in the scale are organised in a 5-point Likert scale where '0' means not at all, '1' means very little, '2' means a little, '3' means quite a lot and '4' means very much. Some of the statements in the scale are reversed, and while calculating the total score of the scale, the reversed statements are subtracted from four and the other statements are directly added to the scoring. The total score that can be obtained from the scale varies between 0-148. A higher total score indicates a better quality of life.
The Pittsburgh Sleep Quality Index	nine weeks	The scale consists of 7 sub-dimensions. Each of the questions including the sub-dimension is scored between 0-3. The total score of the seven sub-dimensions varies between 0-21 and gives the total score of The Pittsburgh Sleep Quality Index. A total score above 5 indicates poor sleep quality.

Trial Locations

Locations (1)

University of Health Science; 🇹🇷 Istanbul, Turkey