Determining the effect of mindfulness based cognitive counseling on the sexual self-esteem of women with breast cancer after mastectomy.
Design
The clinical trial will have an intervention and a control group.
Randomization: random blocks (6 blocks of 4 each) will be divided into two groups of 25 people - a total of 50 people in the intervention group and the control group together, including the possibility of dropping).
This study is a blind strain.
Settings and conduct
The samples are selected from women who refer to Golestan Hospital with total mastectomy and will be placed randomly (6 blocks of 4) in two groups of 25 (the main sample size is 22 ) intervention and control. Demographic and sexual self-esteem questionnaires will be given to people of both groups before and after the intervention to fill.
The researcher will be blind - the test will be conducted by someone other than the researcher.
Participants/Inclusion and exclusion criteria
Married women ; with breast cancer ; in reproductive age ; with total mastectomy surgery ;
After completing the course of chemotherapy and obtaining a score lower than 87 from the sexual self-esteem questionnaire
Non-entry criteria
Having chronic diseases and other cancers
Psychotic people
addiction
metastasis
Participate in the same program
Intervention groups
intervention group : includes training in meditation, mindfulness and cognitive restructuring. Also, self-compassion and kindness towards oneself is also considered. The intervention will consist of 8 face-to-face 90-minute sessions, which will be taught to the people of the intervention group according to the protocol of this treatment.
control group : if the treatment is effective, the people in the control group will receive the same treatment in the offline educational file after the research is completed.
Main outcome variables
Sexual self-esteem and its dimensions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231128060209N1
Registration date:2024-02-05, 1402/11/16
Registration timing:prospective
Last update:2024-02-05, 1402/11/16
Update count:0
Registration date
2024-02-05, 1402/11/16
Registrant information
Name
Sareh Khosravikhorram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4459 7092
Email address
khosravi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-14, 1402/11/25
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mindfulness – based cognitive counseling on sexual self-esteem of women with breast cancer after mastectomy.
Public title
the effect of mindfulness – based cognitive counseling on women with breast cancer .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being married
Having sex with her husband
Having at least one child
Women of reproductive age with breast cancer who have undergone total mastectomy surgery
After completing chemotherapy
Ability to participate in group therapy sessions
possessing at least a middle school education
Breast cancer diagnosis 6 months to 5 years before participating in the research
Obtaining a score lower than 87 from the sexual self-esteem questionnaire
Women aged 30 to 49
Exclusion criteria:
Suffering from chronic diseases such as blood pressure, diabetes and thyroid and autoimmune diseases
Taking Antipsychotic drugs in the last 6 months
Active psychotic disorders
Use of hormone replacement drugs
Drug addiction or dependence on alcohol or psychoactive substances based on the individual's own opinion
Treatment of another type of cancer or malignancy
The occurrence of an unfortunate event during the last 6 months
Participation in concurrent treatment programs to reduce sexual problems and reduce other psychological problems
hysterectomy
metastasis
Age
From 30 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the total sample size is 52 participants (26 participants in each group, considering the potential for drop), selected in the form of 13 blocks of 4. The random allocation of research samples to Group A (control) and Group B (intervention) will be done by generating random sequences, and the formation of blocks will be done using the Random Allocation Software. Each of the generated random sequences is recorded on a registration card, and the cards are placed inside opaque envelopes (13 envelopes). Finally, the sealed envelopes are placed in a box in order. When the study participants who meet the criteria enter, one of the envelopes is randomly opened by a third person, who is a secretary, and the assigned group becomes apparent. Each block consists of 4 patients, and the order of patients being assigned to Group A or B is determined based on the selected block sequence. The fifth patient is again randomly selected from one of the blocks (selected by the secretary), and the type of intervention is assigned to the fifth to eighth patients according to the order of the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the fact that our intervention is a consultation method, it is not possible to blind the researcher, the consultant (specialist related to the treatment) and the participants, so we can only have the blinding of the analyst (statistician).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
School of Nursing and Midwifery - Jundishapur University of Medical Sciences Ahvaz – - Esfand Street – Golestan - Ahvaz - Iran
City
Ahvaz
Province
Khouzestan
Postal code
33337- 61357
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.AJUMS.REC.1402.449
Health conditions studied
1
Description of health condition studied
Sexual self-esteem in women with breast cancer after mastectomy
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Sexual self-esteem of breast cancer patients after mastectomy
Timepoint
Comparison of the scores obtained from the short-form female sexual self-esteem questionnaire (SSEI-W-SF ) before and after the intervention in both intervention and control groups.
Method of measurement
Women's Sexual Self-Esteem Questionnaire of Zeanah and Schwarz Short Form Persian Version .
Secondary outcomes
empty
Intervention groups
1
Description
The intervention will consist of 8 sessions of 90 minutes in one day, but in 2 separate hours and for 2 groups of 12 people. mindfulness based cognitive counseling will be done for the test group. The content of the counseling sessions is according to the protocol of mindfulness treatment and reference books and includes : meditation - breathing exercises - kindness to painful and damaged body parts - cognitive beliefs - home practice, etc. This process will be done in cooperation with Ahvaz University of Medical Sciences and Ahvaz Hospital.
Category
Rehabilitation
2
Description
Control group: If the intervention is effective, the control group will also receive the educational package of Mindfulness based cognitive counseling (including video, audio, PowerPoint, etc.) after completing the study in the form of a CD or file.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Educational and Medical Center of Ahvaz
Full name of responsible person
Parvaneh Mousavi
Street address
Golestan Educational and Medical Center - Farvardin Street -