Effectiveness of online mindfulness base stress reduction intervention on sleep quality, fatigue and psychological well-being among breast cancer patients
Determining the effect of online mindfulness-based stress reduction intervention on sleep quality, fatigue and psychological well-being of breast cancer patients in Birjand in 1400
Design
The sample of this study is based on the number of breast cancer patients undergoing chemotherapy referred to Iran Mehr Hospital in Birjand, by available sampling method; And according to the studies performed in the field of variables studied in this study was calculated.
Settings and conduct
To conduct this research, after the approval of the research ethics committee and receiving the code of ethics, by referring to Iran Mehrshahr Hospital in Birjand, after a complete explanation of the research process, the participants were selected by available sampling method and calculated according to the sample size. Will be done according to the entry and exit criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Having the consent to participate in the study
• The diagnosis of breast cancer has been confirmed by an oncologist and the results of diagnostic tests.
• The patient has the ability to understand, read, write and speak Persian.
• Be between 25 and 60 years old.
No metastasis to other organs.
• The patient is being treated and has received at least one course of chemotherapy.
Has not received any psychological intervention in the past year.
• Have not had a particular stressful accident in the last 6 months.
• The patient is not undergoing other studies or treatments at the same time.
• The patient is not under special psychiatric drug treatment during the intervention or all patients are standardized in terms of drug use
To be.
Intervention groups
Patients with breast cancer undergoing chemotherapy referred to Iran Mehr Hospital in Birjand
Main outcome variables
Improve sleep quality, fatigue and psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220130053878N1
Registration date:2022-06-05, 1401/03/15
Registration timing:retrospective
Last update:2022-06-05, 1401/03/15
Update count:0
Registration date
2022-06-05, 1401/03/15
Registrant information
Name
Zahra Ahmadi Yegane
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4721 0364
Email address
zahra.a.yegane@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
2022-04-21, 1401/02/01
Actual recruitment end date
2022-05-22, 1401/03/01
Trial completion date
2023-07-22, 1402/04/31
Scientific title
Effectiveness of online mindfulness base stress reduction intervention on sleep quality, fatigue and psychological well-being among breast cancer patients
Public title
Effectiveness of online mindfulness base stress reduction intervention on sleep quality, fatigue and psychological well-being among breast cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• Having the consent to participate in the study• The diagnosis of breast cancer has been confirmed by an oncologist and the results of diagnostic tests.• The patient has the ability to understand, read, write and speak Persian.• Be between 25 and 60 years old.No metastasis to other organs.• The patient is being treated and has received at least one course of chemotherapy.Has not received any psychological intervention in the past year.• Have not had a particular stressful accident in the last 6 months.• The patient is not undergoing other studies or treatments at the same time.• The patient is not under special psychiatric drug treatment during the intervention or all patients are standardized in terms of drug use To be.• The patient does not have a specific psychological disorder.
Exclusion criteria:
• Absence of more than two sessions in the program.• Does not have the desire or ability to continue participating in the study.• Death of the patient.
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done using the coin toss method. At the beginning of each day, by referring to Iranmehr Hospital in Birjand, by dropping a coin, it is determined that the first person, for example, is in the test group, the next people are placed one by one in the test and control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari St., Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2021-06-23, 1400/04/02
Ethics committee reference number
IR.BUMS.REC.1400.100
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improve sleep quality, fatigue and psychological well-being
Timepoint
Before the study and immediately after the intervention