Determining the impact of a combined intervention program based on lifestyle on the quality of sleep and occupational fatigue of female nurses
Design
The clinical trial has two intervention and control groups with parallel, randomized groups
Settings and conduct
Female nurses working in Taleghani Hospital and Imam Khomeini Hospital in Urmia who have the inclusion criteria to the study, will be selected and divided into intervention and control groups, and sleep hygiene, progressive muscle relaxation techniques and Aerobic sports will be taught to them. No intervention will be done for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range from 22 to 45, Not having any physical or mental illness or any condition that causes fatigue such as anemia, kidney failure and multiple sclerosis during the last 6 months, Having a bachelor's degree in nursing, Not taking special drugs that affect fatigue, Having rotating work shift, No pregnancy, No breastfeeding, Not having thyroid diseases during the study
Intervention groups
Intervention group: 1) Teaching the principles of sleep hygiene during a virtual session with Sky Room.The file of this content will also be placed on the WhatsApp channel and Doing it daily for up to two months. 2)Teaching Jacobson's method of progressive muscle relaxation by sending an audio file and educational content to the WhatsApp channel and tracking its daily performance for two months.
3) Sending the aerobic exercises prepared by the federation coach to the WhatsApp channel, which will be done by the intervention group on 5 days of the week for two months.
Control group: no intervention will be done.
Main outcome variables
quality of sleep, occupational fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161227031588N5
Registration date:2022-11-06, 1401/08/15
Registration timing:registered_while_recruiting
Last update:2022-11-06, 1401/08/15
Update count:0
Registration date
2022-11-06, 1401/08/15
Registrant information
Name
Haleh Ghavami
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4962
Email address
ghavami.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-01, 1401/08/10
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of lifestyle-based combined intervention program on sleep quality and occupational fatigue of female nurses
Public title
effect of lifestyle-based combined intervention on sleep quality and occupational fatigue of nurses
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age range from 22 to 45
not having any physical or mental illness or any condition that causes fatigue such as anemia, kidney failure and multiple sclerosis in the past 6 months
having a bachelor's degree in nursing
not taking special drugs that affect fatigue
rotating shift
no pregnancy
no breastfeeding
not having thyroid diseases during the study
Exclusion criteria:
Age
From 22 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to determine the samples, a random method will be used. For randomization, the names of the people will be put into a pot, then the first one will be randomly placed in the intervention group and the second one will be placed in the control group, and this will continue until there are 60 people. In this way, the names of the nurses in Taleghani Hospital and similar departments in Imam Khomeini Hospital will be listed, and 30 people will be considered for the intervention group and 30 people will be considered for the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714985454
Approval date
2022-05-25, 1401/03/04
Ethics committee reference number
IR.UMSU.REC.1401.092
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
2
Description of health condition studied
Occupational Fatigue
ICD-10 code
Z73.5
ICD-10 code description
Social role conflict, not elsewhere classified
Primary outcomes
1
Description
sleep quality
Timepoint
Before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
occupational fatigue
Timepoint
Before and after the intervention
Method of measurement
Swedish Occupational Fatigue Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1) teaching the principles of sleep hygiene (using a diet containing tryptophan, not consuming caffeine-containing foods before sleep, having enough physical activity and rest during the day and sleeping between 7 and 8 hours at night) to the intervention group. The training will include a virtual meeting with Skyroom and the file of this content will also be placed on the WhatsApp channel. The daily observance of these principles will be followed up through a self-reporting checklist completed by each person.2) Training of progressive muscle relaxation technique by Jacobson method, which training will be done by sending an audio file and educational content to the WhatsApp channel, and the daily performance of this technique will be followed for two months through a self-reporting checklist completed by each person.3) Sending aerobic exercises prepared by the coach of the sports federation. The prepared exercises will be sent to the WhatsApp channel of the intervention group, which will be carried out 5 days a week for two months by the members of the intervention group.
Category
Prevention
2
Description
Control group: no intervention will be done. At first, the questionnaires of Swedish occupational fatigue and sleep quality of Pittsburgh will be filled by the members of the control group, and after two months these questionnaires will be completed again by these people.