Determining the effect of Benson's relaxation method on the quality of sleep, anxiety, depression and stress of the elderly with knee osteoarthritis
Design
A clinical trial has a control group. 86 patients with conditions to enter the study were selected and assigned to the groups under study by block randomization method and block size of four.
Settings and conduct
The statistical population is all elderly people over 60 years old with knee osteoarthritis who refer to the orthopedic clinic of Shahid Mostafa Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Entry conditions include 1- age over 60 years old; 2- ability to complete the questionnaire; 3- not having dementia (dementia) by obtaining a score of more than 7 from the Abbreviated Mental Test Score (AMTS); 4- obtaining a higher overall score of 5 (meaning poor sleep quality) by the PSQI scale.
The conditions of non-entry include 1- stopping relaxation exercises by the elderly; 2- Suffering from any kind of disease that prevents relaxation exercises; 3- death or travel.
Intervention groups
Intervention: The patient is asked to do Benson's relaxation exercises for 20 minutes twice a day for one month.
Control: In the control group, no intervention is done and the patient receives routine treatment and care.
Main outcome variables
Sleep quality; stress; anxiety; depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230304057605N1
Registration date:2023-04-11, 1402/01/22
Registration timing:prospective
Last update:2023-04-11, 1402/01/22
Update count:0
Registration date
2023-04-11, 1402/01/22
Registrant information
Name
Mohammad Reza Keyhani Dehnavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3309 1461
Email address
mohammadrezakeyhani76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson relaxation technique on sleep quality, anxiety, stress and depression in the elderly with knee osteoarthritis
Public title
The effect of Benson relaxation technique on sleep quality, anxiety, stress and depression in the elderly with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years old
Ability to complete the questionnaire
Obtaining a total score of more than 5 (meaning low sleep quality) by PSQI
Exclusion criteria:
Dementia
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are included in the study by block randomization and parallel allocation. First, by assigning the letter A to the test group and the letter B to the control group, the six states ABBA, BABA, ABAB, BBAA, AABB, BAAB are written on separate sheets and thrown into a container. By chance, one of these sheets is taken out of the container and the combination written on it is remembered, and that sheet is thrown into the container again. Because the sample size in this study is 86 patients, this procedure is repeated 22 times and each time the composition written on each sheet is noted in the sequence of the composition written on the previous sheet. Then, a number from 1 to 86 is assigned to each of the letters in the order of the letters noted in a row. Each letter is placed in an envelope and the number of that letter is written on the envelope. Every time a disease is selected, one of these envelopes is opened according to the number written on the envelope and the patient is placed in the test or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
Shahed University, At the beginning of Tehran- Qhom Road
City
Tehran
Province
Tehran
Postal code
991767994955
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.SHAHED.REC.1401.164
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M19.90
ICD-10 code description
Unspecified osteoarthritis, unspecified site
Primary outcomes
1
Description
Sleep quality score in Pittsburgh Sleep Quality Index
Timepoint
Before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
2
Description
Depression score in Depression, Anxiety and Stress Scale
Timepoint
Before and after the intervention
Method of measurement
Depression, Anxiety and Stress Scale
3
Description
Anxiety score in Depression, Anxiety and Stress Scale
Timepoint
Before and after the intervention
Method of measurement
Depression, Anxiety and Stress Scale
4
Description
Stress score in Depression, Anxiety and Stress Scale
Timepoint
Before and after the intervention
Method of measurement
Depression, Anxiety and Stress Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient is asked to sit, close his eyes, gradually relax his body muscles from the tip of the toes to the face, inhale through the nose and slowly exhale through the mouth. Be aware of your breathing and repeat in your mind the word that always reminds you of peace in every exhalation. The patient continues these exercises for 20 minutes. After this period, they keep their eyes closed for a few minutes and then open their eyes. This exercise is done twice a day for 1 month.
Category
Treatment - Other
2
Description
Control group: No intervention is performed in the control group.