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The Effect Of Progressıve Relaxatıon Exercıses

Primary Purpose

Sleep Disturbance, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
progressive relaxation egzersize
Sponsored by
Seren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Disturbance focused on measuring Nurse, Progressive Relaxation, Sleep, Intensive Care, Fatigue

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Without a psychiatric diagnosis,
  • Having a score of PUKI ≥5 and YŞÖ≥4,
  • Nurses who volunteered to participate in the study were included in the research sample.

Exclusion Criteria:

  • Experience of working in intensive care for less than 3 months,
  • Using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine, antidepressant, anxiolytic and narcotic analgesics that affect sleep quality,
  • Pregnant nurses were not included in the research sample.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention: progressive relaxation exercise practice group

control: uninterrupted group

Arm Description

intervention: progressive relaxation exercise practice group: A group of 30 intensive care nurses who will practice the progressive relaxation exercise at home 3 days a week for 1 month.

control: A group of 30 intensive care nurses who did not intervene for 1 month

Outcomes

Primary Outcome Measures

Post-application fatigue severity rate of nurses working in the intensive care unit
Fatigue severity scale The scale developed by Krup (1989) is a nine-item scale that evaluates the overall effect of fatigue on daily activities.In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. The total score is calculated by taking the average of nine items. The cut-off value for pathological fatigue was determined as 4 and above. The lower the total score, the less fatigue.
Decrease in sleep quality scale scores after the application
The Pittsburgh Sleep Quality Index (PUKI, PSQI) was developed in 1989 by Buysse et al. (Buysee et al, 1989) to evaluate sleep quality in the last month. The scale consists of a total of 24 questions, 19 of which were answered by the individual and five of them by the relatives of the individual.Each item score varies between "0" and "3", and the sum of the scores of the items in the seven components gives the scale score of 18.The total PUKI score ranges from 0 to 21. If this score is above 5, it indicates that the sleep quality of the individual is poor.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
July 1, 2021
Sponsor
Seren
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1. Study Identification

Unique Protocol Identification Number
NCT04959214
Brief Title
The Effect Of Progressıve Relaxatıon Exercıses
Official Title
The Effect of Progressive Relaxation Exercises Applied to Nurses Working in the Intensive Care Unit on Sleep Quality and Fatigue Severity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seren

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was conducted to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit three times a week for 1 month on sleep quality and severity of fatigue. The research is a pretest-posttest randomized controlled study with an intervention control group.
Detailed Description
The Effect of Progressive Relaxation Exercises Applied to Nurses Working in The İntensive Care Unit on Sleep Quality and Fatique İntensity The study was planned to determine the effect of progressive relaxation exercises applied to nurses working in intensive care units on sleep quality and fatigue intensity. The study will be conducted with a randomized controlled experimental research design in order to evaluate the effect of progressive relaxation exercises applied to nurses working in the intensive care unit on sleep quality and fatigue intensity. This randomized controlled study will be conducted on nurses working in Adana City Training and Research Hospital Intensive Care Unit. Nurses will be divided into 2 groups as experiment and control. It will be carried out on 60 people in total, 30 for the experimental group, 30 for the control group. Progressive relaxation exercises will be applied by nurses for 45 minutes, 3 days a week for an average of 1 month. The data of the study will be collected after the purpose of the study is explained to the nurses and their verbal and written consents are obtained. In the collection of research data, the Personal Information Form prepared by the researchers and containing the introductory information of the nurses, the Pittsburgh Sleep Quality Index (Pittsburgh Sleep Quality Index Scale PSQI), the Fatigue Severity Scale for fatigue (FSS) will be collected from control and intervention groups through face-to-face interviews. There are a limited number of studies showing the effects of progressive relaxation exercises applied to intensive care nurses on sleep quality and fatigue intensity in our country. With the study, the use of these exercise programs, which can be easily applied by nurses who work under heavy workloads in the intensive care environment, will increase, and it will be ensured that nurses work more fit and efficiently and are supported in terms of sleep fatigue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Fatigue
Keywords
Nurse, Progressive Relaxation, Sleep, Intensive Care, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention: progressive relaxation exercise practice group
Arm Type
Experimental
Arm Description
intervention: progressive relaxation exercise practice group: A group of 30 intensive care nurses who will practice the progressive relaxation exercise at home 3 days a week for 1 month.
Arm Title
control: uninterrupted group
Arm Type
No Intervention
Arm Description
control: A group of 30 intensive care nurses who did not intervene for 1 month
Intervention Type
Behavioral
Intervention Name(s)
progressive relaxation egzersize
Intervention Description
Performing exercises in a quiet environment for 45 minutes with the Turkish Psychologists Association CD. Filling the PSQI and FSS before and 1 month after the application
Primary Outcome Measure Information:
Title
Post-application fatigue severity rate of nurses working in the intensive care unit
Description
Fatigue severity scale The scale developed by Krup (1989) is a nine-item scale that evaluates the overall effect of fatigue on daily activities.In the scale, individuals are asked to rate the fatigue they have felt during the past week from 1 to 7. The total score is calculated by taking the average of nine items. The cut-off value for pathological fatigue was determined as 4 and above. The lower the total score, the less fatigue.
Time Frame
Scales are filled before starting the application and at the end of the application after 1 month.
Title
Decrease in sleep quality scale scores after the application
Description
The Pittsburgh Sleep Quality Index (PUKI, PSQI) was developed in 1989 by Buysse et al. (Buysee et al, 1989) to evaluate sleep quality in the last month. The scale consists of a total of 24 questions, 19 of which were answered by the individual and five of them by the relatives of the individual.Each item score varies between "0" and "3", and the sum of the scores of the items in the seven components gives the scale score of 18.The total PUKI score ranges from 0 to 21. If this score is above 5, it indicates that the sleep quality of the individual is poor.
Time Frame
Scales are filled before starting the application and at the end of the application after 1 month.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Without a psychiatric diagnosis, Having a score of PUKI ≥5 and YŞÖ≥4, Nurses who volunteered to participate in the study were included in the research sample. Exclusion Criteria: Experience of working in intensive care for less than 3 months, Using antidepressant, antihistamine, diuretic, hypnotic, benzodiazepine, antidepressant, anxiolytic and narcotic analgesics that affect sleep quality, Pregnant nurses were not included in the research sample.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songül Karadağ
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University
City
Sarıçam
State/Province
Adana
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Results of intervention and control group scales before and after administration (statistical analysis) Introductory characteristics of the participants and participant consent form
IPD Sharing Time Frame
Data is continuously available after publication
IPD Sharing Access Criteria
Data can be shared publicly
IPD Sharing URL
https://tez.yok.gov.tr/UlusalTezMerkezi/

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The Effect Of Progressıve Relaxatıon Exercıses

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