Assessment of the Effect of a Nursing Care Program Based on the Roy's Adaptation Model on the Quality of Sleep of People with Opioid Abuse under Methadone Maintenance Therapy
Determining the effect of a Nursing Care Program Based on the Roy's Adaptation Model on the Quality of Sleep of People with Opioid Abuse
Design
Intervention group: the researcher uses the Assessment form based on the Roy's Adaptation Model, conducts and evaluates the research and recognition based on the nursing process in the test group, and evaluates the nursing process based on the Roy model for them for three months. He also completes the questionnaires immediately before the intervention and three months after the start of the study.
Comparison group: During this period, they will receive the prescribed routine treatments. They only complete the mentioned questionnaires in the pre-test and post-test stages.
Settings and conduct
the samples from the Article 16 Injury Reduction Center of Isfahan will be selected by available sampling method and again by random sampling method using block classification will be assigned to two groups.
The intervention group will be cared for for 3 months based Roy's Adaptation Model.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Be able to read and write.
Based on his report, he should have a suitable general situation to complete the questionnaire.
Have more than six months of continuous opioid abuse
Exclusion criteria:
Having severe physical and mental illnesses
Participate in another similar study simultaneously
Intervention groups
A clinical trial with a control group, with parallel, randomized groups, on 60 patients with opioid abuse who were randomly divided into two groups of experimental and control.
Main outcome variables
Quality of Sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N6
Registration date:2022-11-26, 1401/09/05
Registration timing:prospective
Last update:2022-11-26, 1401/09/05
Update count:0
Registration date
2022-11-26, 1401/09/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of a Nursing Care Program Based on the Roy's Adaptation Model on the Quality of Sleep of People with Opioid Abuse under Methadone Maintenance Therapy
Public title
Assessment of the Effect of a Nursing Care Program Based on the Roy's Adaptation Model on the Quality of Sleep of People with Opioid Abuse
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Be able to read and write.
Based on his report, he should have a suitable general situation to complete the questionnaire.
Have more than six months of continuous opioid abuse
Exclusion criteria:
Having severe physical and mental illnesses
Participate in another similar study simultaneously
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a block with size 4. Randomization unit: individual. Random allocation software. Random chain concealment is by placing patient codes in opaque envelopes.
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
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Research Ethics Committee, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.088
Health conditions studied
1
Description of health condition studied
Drug addiction
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family
Primary outcomes
1
Description
Quality of Sleep
Timepoint
Immediately before the intervention and three months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the researcher uses the Assessment form based on the Roy's Adaptation Model, conducts and evaluates the research and recognition based on the nursing process in the test group, and evaluates the nursing process based on the Roy model for them for three months.
Category
Other
2
Description
Control group: During this period, they will receive the prescribed routine treatments. They only complete the mentioned questionnaires in the pre-test and post-test stages.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Harm Reduction Center Article 16 of the city of Isfahan