The Effect of Progressive Muscle Relaxation Exercise on Sleep Quality

NCT05604820 | Completed

• 1 other identifier: KARATAY.ebru.sari001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy is applied as a standard method in the treatment of cancer, which is an important public health problem in terms of incidence and mortality. Sleep quality due to cancer and its treatments is adversely affected. Cognitive behavioral therapies, walking and relaxation exercises are known to be beneficial in increasing sleep quality. For this reason, this study will be conducted to evaluate the effect of progressive muscle relaxation exercises applied to individuals who are undergoing chemotherapy and whose sleep quality has deteriorated, on sleep quality. The research will be carried out between March and September 2022 in Konya City Hospital Chemotherapy Unit with patients undergoing chemotherapy. Patients who will receive chemotherapy will be informed about the study, and those who accept to participate in the study will be evaluated according to the inclusion and exclusion criteria of the sample selection. They will be asked to fill out the PUKI. It will then be assigned to the control or experimental group with the randomization program assignment. Training on progressive muscle relaxation exercises will be given to the experimental group in the chemotherapy unit. Before going to sleep in the evening and during the day, they will be asked to do progressive muscle relaxation exercises in line with the instruction of the video. They will be asked to do the application every day for 8 weeks. At the end of the 2nd week, 4th week, 6th week and 8th week, they will be asked to fill the PUKI again. Only routine care will be applied to the control group and no intervention will be made. At the end of the 2nd week, 4th week, 6th week and 8th week, they will be asked to fill the PUKI again. After the evaluations, information about progressive muscle relaxation exercises will be given.

Conditions

Cancer Patients

Outcome Measures

Primary Outcomes (1)

• quality of sleep

  measuring the effect of progressive November relaxation exercise on sleep quality

  two months

Study Arms (2)

experimental

EXPERIMENTAL

Progressive Muscle Relaxation Exercise

Behavioral: Progressive Muscle Relaxation Exercise

no ıntervention

NO INTERVENTION

Interventions

Progressive Muscle Relaxation Exercise BEHAVIORAL

Training on progressive muscle relaxation exercises will be given to the experimental group in the chemotherapy unit. Before going to sleep in the evening and during the day, they will be asked to do progressive muscle relaxation exercises in line with the instruction of the video. They will be asked to do the application every day for 8 weeks. At the end of the 2nd week, 4th week, 6th week and 8th week, they will be asked to fill the PUKI again. Only routine care will be applied to the control group and no intervention will be made. At the end of the 2nd week, 4th week, 6th week and 8th week, they will be asked to fill the PUKI again. After the evaluations, information about progressive muscle relaxation exercises will be given.

experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pittsburgh Sleep Quality Index (PUKI) score, which is 5 points and above,
• who are 18 years of age or older,
• \* Who will receive outpatient chemotherapy in the chemotherapy unit,
• Knows how to read and write,
• Using mobile phone conveniently to upload progressive November relaxation exercise video, \* Who volunteered to participate in the research.

You may not qualify if:

• \* Hearing impaired,
• Receiving radiotherapy treatment,
• Who has a physical disability to perform relaxation exercises,
• Depression, schizophrenia, etc. with a diagnosis of psychiatric illness,
• With neurological disorders,
• With a metastatic condition,
• Antidepressants or sleeping pills, etc. using medication,
• Relaxation exercise (yoga, breathing and meditation, etc.) acting.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Kto Karatay üniversitesi

Konya, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the characteristics of the study, blinding cannot be applied to the participants. In order to eliminate the bias, the data of the study will be collected and recorded by an impartial researcher (assistant researcher) who does not know the groups trained by the researcher. The statistics of the research will be carried out by an independent statistician who does not know the groups. In this way, the prevention of bias will be ensured.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized Controlled Study

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 3, 2022
• Study Start: October 31, 2022
• Primary Completion: February 7, 2023
• Study Completion: April 10, 2023
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)