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Investigating the effect of logo therapy on existential anxiety, and mindfulness in breast cancer patients who have undergone mastectomy

Protocol summary

Study aim
Determining the effect of logo therapy on existential anxiety, and mindfulness in breast cancer patients who have undergone mastectomy
Design
It will be a randomized Clinical Trial, two-group, two-phase clinical trial that will be conducted on 70 patients with mastectomy breast cancer. Random allocation will be done by generating a random sequence by the software in two groups.
Settings and conduct
The research environment is Seyed al-Shohda Hospital. The sample of study will be patients with mastectomy breast cancer. The sessions of the logotherapy program will be held in 8 sessions of 45 minutes and three times a week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to read, write and speak Persian language, willingness and full consent to cooperate in the study, maximum age of 70 years, awareness of one's illness, no acute or chronic mental disorders based on self-report, no speech and hearing disorders, no consumption of psychoactive and addictive substances, has not experienced severe stress during the past 6 months, not participating in another similar educational program at the same time, not having expertise in fields related to psychology and counseling, must have gone through the recovery stage and reached a level of stability. Non-entry criteria: reluctance to continue cooperation, desire to change the hospital, sudden death of the patient, in the case of patients in the test group, more than 2 absences
Intervention groups
For the test group, 8 sessions of 45 minutes will be held three times a week, and the programs of the test group include a training booklet that will be provided to each member The control group will receive only the care and routine training of the department. At the end of the research, the presented content will be available to the people of the control group
Main outcome variables
Existential anxiety; Mindfulness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240310061242N1
Registration date: 2024-03-24, 1403/01/05
Registration timing: prospective

Last update: 2024-03-24, 1403/01/05
Update count: 0
Registration date
2024-03-24, 1403/01/05
Registrant information
Name
Fatemeh Ghaedi-Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7607
Email address
fatemeh.ghaedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of logo therapy on existential anxiety, and mindfulness in breast cancer patients who have undergone mastectomy
Public title
Investigating the effect of logo therapy on existential anxiety, and mindfulness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have the ability to read, write and speak Persian The patient must be willing and fully satisfied to cooperate in the study The patient must be at least 70 years old Patients who are aware of their disease The patient does not have acute or chronic mental disorders based on self-report The patient does not have speech and hearing disorders The patient should not use psychoactive and addictive substances During the past 6 months, has not experienced severe stress such as the death of relatives or divorce The patient should not participate in another similar educational program at the same time The patient does not have expertise in fields related to psychology and counseling The samples under the present study must have gone through the recovery stage and reached a level of stability
Exclusion criteria:
Does not want to continue cooperation The patient wants to change the hospital Sudden death of the patient occurs In the case of patients in the test group, there should be absent for more than 2 sessions
Age
To 70 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
People who meet the entry criteria will be asked to consent to participate in this research and then they will enter the study. The samples will be placed in two groups (control and test) by random allocation method by generating a random sequence by the software. If there is a significant difference in the two groups in terms of demographic information, the analysis of covariance test will be used to minimize the difference in the two groups.
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 in Research Faculty of Nursing, Management and Rehabilitation - Isfahan University
Street address
Research Assistant, Isfahan University of Medical Sciences, Hazar Jarib St.,Isfahan,Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Approval date
2024-02-26, 1402/12/07
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.188

Health conditions studied

1

Description of health condition studied
Patients with mastectomy breast cancer
ICD-10 code
C50-C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Existential anxiety in mastectomized breast cancer patients
Timepoint
The beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Lawrence Good existential anxiety questionnaire

2

Description
Mindfulness in mastectomized breast cancer patients
Timepoint
The beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Bauer et al. Mindfulness Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: for the test group, 8 sessions of 45 minutes will be held three times a week with content such as the meaning of life and its necessity in life, suffering and finding meaning through face-to-face training with patients, and the programs of the test group include booklets. It is a training that will be provided to each member of the test group. A number of sessions are performed during hospitalization and some are performed after discharge due to the limited duration of hospitalization and the number of intervention sessions. For this purpose, a list of the names and contact numbers of the patients of the intervention group will be prepared before the start of the intervention, and the remaining sessions will be coordinated with the patients after discharge. Also, the patients of the test group are asked to apply the principles learned in the sessions.
Category
Other

2

Description
Control group: In this study, the control group receives only the care and routine training of the department. In order to comply with ethical standards at the end of the research, the presented content will be available to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed-shohada Hospital
Full name of responsible person
Mahgol Nasr Esfahani
Street address
Seyed al-Shohada Hospital, Farshadi Creek, At the end of Motahari St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3235 0210
Email
fatemeh.ghaedi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Nursing and Midwifery Faculty., Isfahan University of Medical Sciences., Hezerjerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mahgol Nasr Esfahani
Position
Msc in psychiatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7507
Email
mahgolnasrr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Ghaedi-Heidari
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7507
Email
fatemeh.ghaedi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Ghaedi-Heidari
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7507
Email
fatemeh.ghaedi@gmail.com

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
Not applicable
Data Dictionary
Not applicable
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