]>
IRCT20231114060057N2 IRCT 2024-10-17 Shahroud University of Medical Sciences The Effect of Reflexology on Anxiety Symptoms, Pain Intensity and Sleep Quality in Breast Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial The Effect of Reflexology on Anxiety Symptoms, Pain Intensity and Sleep Quality in Breast Cancer Patients Undergoing Chemotherapy: A Parallel Randomized Clinical Trial 2024-11-21 anticipated 60 Complete https://irct.ir/trial/79440 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be included in the study based on the inclusion and exclusion criteria through purposive sampling. They will then be randomly assigned to two groups: Group A (intervention) and Group B (control) based on quadruple blocks. The sequence of random allocation will be determined by SPSS software. With a sample size of 60 people, 15 quadruple blocks will be considered. Participants will be randomly assigned to their respective groups based on the order of entry into the study and the quadruple blocks. N/A Breast cancer. Intervention 1: Intervention group: In the intervention group, reflexology will be performed once a week for three weeks, with each session lasting half an hour and taking place after each chemotherapy session. The patient will be prepared, and their feet will be lubricated with sweet almond oil. The researcher will then conduct a relaxing massage on both feet 3-4 times for 10 minutes each, followed by a 20-minute session focusing on the treatment points on the soles of both feet. Intervention 2: Control group: The control group will only receive the usual care provided by the treatment center. Yes - There is a plan to make this available What will be shared: The demographic and clinical characteristics of the participants, as well as all information related to their anxiety symptoms, pain intensity, and sleep quality, can be shared while maintaining confidentiality and not using the names of the participants. When: After publishing the article To whom: Project partners Conditions: For people doing similar research work. Where to obtain: The person in charge of the project should be contacted via email: abbasi_msn@yahoo.com How to obtain: Data will be provided to people through email. Comments:
public Saeed Ghasempour
University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3614773943 +98 23 3239 5054 s.ghasempoor.2675@gmail.com Shahroud University of Medical Sciences scientific Ali Abbasi
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
Shahroud Iran (Islamic Republic of) 3614773943 +98 23 3239 5054 abbasi_msn@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive breast cancer diagnosis by a specialist physician Age above 18 years Speaking Persian 18 years no limit Female Received reflexology in the past Receiving radiation therapy as the first complementary treatment or concurrently Having any bleeding, seizures, or fever Having varicose veins and any foot disease, including open wounds or fractures Having any psychiatric disorder or dementia Male gender C50 Malignant neoplasm of breast N/A N/A Intervention group: In the intervention group, reflexology will be performed once a week for three weeks, with each session lasting half an hour and taking place after each chemotherapy session. The patient will be prepared, and their feet will be lubricated with sweet almond oil. The researcher will then conduct a relaxing massage on both feet 3-4 times for 10 minutes each, followed by a 20-minute session focusing on the treatment points on the soles of both feet. Control group: The control group will only receive the usual care provided by the treatment center. Anxiety symptoms. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Generalized Anxiety Disorder Questionnaire. Pain intensity. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Numerical Rating Scale. Sleep quality. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Shahroud University of Medical Sciences Approved 2024-04-15 Ethics Committee of Shahroud University of Medical Sciences University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran. Shahroud Semnan Iran (Islamic Republic of)