The effect of mindfulness training on anxiety and sleep quality of informal caregivers of cancer patients in Bushehr city in 2024
Design
The study has a control group with parallel groups, randomized, on 70 caregivers. Blocking is used for randomization.
Settings and conduct
Eight sessions of mindfulness will be provided to intervention group in a quiet environment with audio and video training facilities.the questionnaires will be completed before, immediately and one month after the intervention in both the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Women aged 18 and older
Care of patients 18 years and older
At least three months have passed chemotherapy,radiotherapy and surgery
Having the ability to read and write in Persian language
Obtaining an anxiety score of 32 and above (average level of anxiety) based on the Spielberger questionnaire
Exclude criteria:
Caring for patients who are in the acute phase of the disease
Declaring the existence of a sleep disorder before accepting the role of caregiver
History of mental disorders
Substance abuse based on the person's self-report
Death of a relative in the past year
Suffering from any kind of illness or medical condition of the caregiver during the intervention that prevents her from attending the mindfulness sessions
Participation in other psycho-social programs, meditation and yoga exercises
Death of the patient or her/his unwellness during the intervention
Intervention groups
Eight mindfulness intervention sessions will be provided in the intervention group.
In the control group, there will be no intervention.
Main outcome variables
Examining anxiety and sleep quality in caregivers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240310061244N1
Registration date:2024-04-30, 1403/02/11
Registration timing:prospective
Last update:2024-04-30, 1403/02/11
Update count:0
Registration date
2024-04-30, 1403/02/11
Registrant information
Name
Aazam Hosseinnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 0187
Email address
a.hosseinnezhad@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-14, 1403/02/25
Expected recruitment end date
2024-07-15, 1403/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness training on anxiety and sleep quality of informal caregivers of cancer patients
Public title
The effect of mindfulness training on anxiety and sleep quality of informal caregivers of cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent and informed desire to participate in the research
Women aged 18 and older living in Bushehr city
Care of patients 18 years and older
At least three months have passed chemotherapy,radiotherapy and surgery
The patient's statement that he/she accepts the role of the participant as the main caregiver
Participant's statement that she has the role of the main caregiver of the patient
Not getting paid for providing care services
Having the ability to read and write in Persian language
Obtaining an anxiety score of 32 and above (average level of anxiety) based on the Spielberger questionnaire
Exclusion criteria:
Caring for patients who are in the acute phase of the disease (metastatic)
Declaring the existence of a sleep disorder before accepting the role of caregiver (self-reporting or taking medication)
History of mental disorders (self-reported or drug use)
Substance abuse based on the person's self-report
Death of a relative in the past year
Suffering from any kind of illness or medical condition of the caregiver during the intervention that prevents her from attending the mindfulness sessions
Participation in other psycho-social programs, meditation and yoga exercises
Death of the patient or her/his unwellness during the intervention
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be used based on a block design with a block size of 4, 6, and 8.
A block randomization design will be generated using the free website below.
(Seed: 188521504972600) https://www.sealedenvelope.com
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 Bushehr University of Medical Sciences
Street address
No. 25, 5 Danesh Alley ,Khajaha
City
Bushehr
Province
Boushehr
Postal code
7516955975
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.BPUMS.REC.1403.011
Health conditions studied
1
Description of health condition studied
Investigating the effect of mindfulness on anxiety and sleep quality of informal caregivers of cancer patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Spielberger anxiety questionnaire
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Intervention groups
1
Description
Intervention group: Mindfulness training
Category
Other
2
Description
Control group: Comparison group - no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr Persian Gulf Martyrs Hospital
Full name of responsible person
Jalalian Zahra Sadat
Street address
Persian Gulf Martyrs Hospital, BLV Azadi, Bushehr
City
Bushehr
Province
Boushehr
Postal code
Phone
+98 77 3345 5375
Email
Zahrajalali661@ Yahoo.Com
2
Recruitment center
Name of recruitment center
Shafa Hematology Clinic
Full name of responsible person
Rekabpour Seyyed Javad
Street address
Nurse St, West Lian St, Bushehr
City
Bushehr
Province
Boushehr
Postal code
Phone
+98 939 156 6101
Email
Seyed.Rekab@ Gmail.Com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Malekizadeh Hassan
Street address
Bushehr University of Medical Sciences, Salman Farsi Blv, Shahid Yasini Blv, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
daneshkedepezeshki@Bpums.Ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Hossein Nejad Azam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bushehr University of Medical Sciences, Salman Farsi Blv, Yasini Blv, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
a.hosseinnezhad@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Hossein Nejad Azam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bushehr University of Medical Sciences, Salman Farsi Blv, Yasini Blv, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
a.hosseinnezhad@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Hossein Nejad Azam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bushehr University of Medical Sciences, Yasini Blv, Salman Farsi Blv, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 2227
Email
a.hosseinnezhad@bpums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available