1. Determining the average score of sleep quality in postmenopausal women in the test group, before and after the intervention
2. Determining the average sleep quality score in postmenopausal women in the control group, before and after the intervention.
3. Comparing the average score of sleep quality before the intervention between the intervention and control groups
4. Comparing the average score of sleep quality after the intervention between the intervention and control groups
Design
A clinical trial, with a control group, double-blind, randomized, will be conducted on 44 postmenopausal women. Block random allocation method will be used for randomization.
Settings and conduct
The clinical trial will be conducted on the samples referred to comprehensive health centers of Larestan City. The required data will be completed by demographic questionnaires before the intervention and the Pittsburgh Sleep Questionnaire in two stages before and after the intervention.. In the intervention group, spiritual reminiscence will be performed for 3 weeks, and in the control group, routine care will be performed. In this study, double blinding will be used to blind the researcher and statistical analyst.
Participants/Inclusion and exclusion criteria
Entry conditions: at least 50 years old, one year post menopause
Non-entry Conditions: under hormonal treatment, having underlying diseases
Intervention groups
Patients in the intervention group undergo spiritual reminiscence for a specified period (3 weeks) and women in the control group receive routine care. Immediately after the end of the intervention, the Pittsburgh sleep questionnaire will be provided to the study samples again.
Main outcome variables
The demographic questionnaire before the intervention and the Pittsburgh Sleep Questionnaire will be completed before the intervention and immediately after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240204060893N1
Registration date:2024-03-24, 1403/01/05
Registration timing:registered_while_recruiting
Last update:2024-03-24, 1403/01/05
Update count:0
Registration date
2024-03-24, 1403/01/05
Registrant information
Name
Fateme Zeraatpisheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5335 0994
Email address
zeraatpishe.f1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-24, 1402/12/05
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual reminiscence on the sleep quality of postmenopausal women: A clinical trial study
Public title
Investigating the effect of spiritual reminiscence on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 50 years old
At least one year has passed since menopause
Not having a history of hysterectomy and oophorectomy
Having a sleep quality disorder according to the Pittsburgh Questionnaire (score 5 and above)
Able to cooperate to complete the questionnaire and carry out the intervention
Exclusion criteria:
Having Restless Leg Syndrome
Mental illnesses based on disease records and medical records
Regular use of sedatives and hypnotics
Under hormonal treatment
Alcohol and drug use routinely
Having a mental crisis in the last 6 months, such as a divorce or losing a family member
Having records of reminiscence intervention
Having incurable underlying diseases such as cancers and nerve diseases that lead to mental disorders of the patient
Age
From 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
After examining the applicants in terms of their eligibility to enter the study, they will be included in one of the intervention groups or the control group through the process of random block allocation and in accordance with the principle of blinding. The intervention and control groups are named group A and group B, Random allocation will be done through random block allocation with a block size of 4 and with equal probability in each group. Given a block size of 4, we will have six possible combinations of intervention random assignment states, which will include AABB, ABAB, BAAB, BABA, BBAA, and ABBA. At first, one of these modes of intervention allocation order will be randomly selected and four eligible clients will be assigned to intervention and control groups based on that in each block and based on the order of intervention allocation. This process will be repeated many times until eligible people referring to community health centers are completely allocated in each group and based on the specified number using the sample size formula.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because of the content of the intervention, which is spiritual reminiscence, it is not possible to blind the patient, In this study, double blinding will be used to blind the researcher and statistical analyst. During the process of random allocation, the researcher will not be aware of the type of groups and only the letters A and B will be used to name the groups. in the stages of statistical analysis to avoid bias, the letters A and B will be used to identify the intervention and control groups in the statistical software (Value0,1&lable A,B) In order to avoid the bias and application of the personal opinion of the researcher and statistical analyst in reaching the desired results..
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Larestan Faculty of Medical Sciences
Street address
Karmand St, North Ghadir Blvd, Shahr_eJadid
City
Larestan
Province
Fars
Postal code
74318-95639
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.LARUMS.REC.1402.029
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.9
ICD-10 code description
Unspecified menopausal and perimenopausal disorder
Primary outcomes
1
Description
Sleep quality based on the Pittsburgh Sleep Quality Questionnaire
Timepoint
Completing the questionnaire before the intervention and after the last session of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
No intervention will be done in the control group
Category
N/A
2
Description
The intervention framework in this study is based on six themes extracted from in-depth interviews with older adults using grounded theory in the study conducted by MacKinlay (2006). Spiritual themes correspond to the psychosocial stages identified by Erikson et al. (1986). Meaning in this study means focusing on the meaning of events and experiences in the life of the participants, instead of just explaining the events. In this study, each session will discuss a topic in the intervention group. According to past research on spiritual reminiscence, each intervention session is about 1 hour. 5 minutes of warm-up phase for people in the group to discuss, 50 minutes of active phase and 5 minutes of closing phase and the therapist thanks the group members. Also, this intervention can be done once or twice a week in a group or individual form. Therefore, in the current study, spiritual reminiscence will be done for the study samples in a group, twice a week for 3 weeks for each person and for 1 hour each time, for a total of 6 hours. It should be noted that in order to make the conditions of women under spiritual reminiscence the same, a two-day interval will be considered between two interventions in each week. Thus, if it is decided that the women in the intervention group will receive the first spiritual reminiscence intervention on Saturday, it will be decided that their second session will be held on Monday at the same time as Saturday. Later interventions are performed in the following weeks on the same day and hours. A room with minimal noise and sufficient light will be used for the study. Also, before starting the study, it is tried to reduce the stress and anxiety of the study samples and resolve their ambiguities by fully clarifying the process of doing the work and its purpose. At this stage, the intervention will begin after the women are fully prepared to start the study. The women in the test group will gather together in the designated room. The space of this room will be such that it will have enough space for the presence of women. The topics and content of each session will include: the meaning of life, relationships-isolation, communication, hopes, fears and worries, aging and transcendence, spiritual and religious beliefs, spiritual and religious practices.In the formed group, the sessions will be led by the researcher and the duration of each session will try not to exceed 1 hour in order to avoid fatigue of the participants.These sessions will be educational, supportive, question and answer, discussion and exchange of patients' experiences. In order to facilitate the transfer of information and empathy, the participants in the meeting will be seated in a circle and the leader of the group will be in full view of all the members of the group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Community health centers of Larestan city
Full name of responsible person
Mohammad-Rafi Bazrafshan
Street address
Doktor Dadman highway
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Email
mrbazr@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr. Mohamma-Hossein Karimi
Street address
New City, Northern Ghadir Blvd, Karmandan St., behind Larestan Grand Bazaar, Sina Building (Larestan College of Medical Sciences)
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
New City, Northern Ghadir Blvd., Karmandan St., behind Larestan Grand Bazaar, Sina Building (Larestan faculty of Medical Sciences)
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
New City, Northern Ghadir Blvd., Karmandan St., behind Larestan Grand Bazaar, Sina Building (Larestan College of Medical Sciences)
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
New City, Northern Ghadir Blvd., Karmandan St., behind Larestan Grand Bazaar, Sina Building (Larestan College of Medical Sciences)
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
mrbazr@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It can be shared after de-identifying people
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
People working in academic and scientific institutions
Under which criteria data/document could be used
With the agreement of Larestan Faculty of Medical Sciences
From where data/document is obtainable
Dr. Mohammad-Rafi Bazrafshan. Associate Professor of Larestan Faculty of Medical Sciences. Email address: mrbazr@sums.ac.ir.
Phone Call:07152247110
phone number: 09173821959
What processes are involved for a request to access data/document
A written and official request to the Research Assistance of Larestan Faculty of Medical Sciences