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Comparison of the effectiveness of a designed pain management program and Mindfulness-Based Interoceptive Exposure Task [MIET] on experienced pain and life expectancy of breast cancer patients

Protocol summary

Study aim
Comparison of the effectiveness of a designed pain management program and Mindfulness-Based Interoceptive Exposure Task [MIET] on experienced pain and life expectancy of breast cancer patients
Design
Clinical trial, with control group, with parallel groups, without blinding, in which 45 breast cancer patients with neuropathic pain will be randomly assigned to three groups.
Settings and conduct
The study population will be breast cancer patients aged 18 to 70 years who suffer from pain referred to the Namazi Medical Center. They will be assigned to three groups randomly (through lottery). The intervention of pain management and MIET intervention is a group therapy during 6 weekly sessions of 120 minutes in the conference hall of Namazi Hospital-Motahari Clinic located on the ground floor, which is designed for group interventions. The control group received no psychological intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 to 70 years, Having breast cancer type 1 to 3, Receiving chemotherapy, Suffering from pain experienced during chemotherapy, Minimum diploma education. Exclusion criteria: Unwillingness to participate in meetings, Receiving individual psychological interventions, Receiving strong painkillers.
Intervention groups
Intervention group 1: They will receive group training on the pain management program during 6 sessions of 120 minutes which is compiled based on the background and theories of pain. Intervention group 2: They will receive group training on mindfulness-based internal exposure therapy (MIT), during 6 sessions of 120 minutes, which is teaching mindfulness, a different way of facing pain. Control group: This group goes through the usual process of cancer treatment and does not receive a psychological intervention.
Main outcome variables
Pain experienced, hope for life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220903055860N1
Registration date: 2022-09-29, 1401/07/07
Registration timing: registered_while_recruiting

Last update: 2022-09-29, 1401/07/07
Update count: 0
Registration date
2022-09-29, 1401/07/07
Registrant information
Name
Mohsen Arefian
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 4050
Email address
m.arefian92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-21, 1401/06/30
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of a designed pain management program and Mindfulness-Based Interoceptive Exposure Task [MIET] on experienced pain and life expectancy of breast cancer patients
Public title
Comparison of designed pain management program and internal exposure on pain experienced in breast cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer diagnosis Receive chemotherapy experience pain Agreeing to participate in the research
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to 3 groups of 15 using simple randomization (by lottery method).
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
Research Ethics Committees of University of Isfahan
Street address
Azadi Square, University Street, Isfahan University, Department of Education and Graduate Studies
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Approval date
2022-08-06, 1401/05/15
Ethics committee reference number
IR.UI.REC.1401.059

Health conditions studied

1

Description of health condition studied
Patients with breast cancer who suffer from pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain experienced
Timepoint
Before intervention, immediately after intervention, 1 month after intervention
Method of measurement
Brief pain intensity questionnaire (Klind, 1991)

Secondary outcomes

1

Description
life expectancy
Timepoint
Before intervention, immediately after intervention, 1 month after intervention
Method of measurement
Life expectancy questionnaire of Snyder, Harris and Anderson (1991)

Intervention groups

1

Description
Intervention group1: They will receive group training on the designed pain management program through 6 120-minute sessions. This intervention includes the introduction of the group and cancer and treatment stages, inviting two people who have recovered from breast cancer to express their experiences, introducing harmful thoughts and behaviors during chemotherapy, teaching the concept of acceptance and avoidance, and finally training Techniques that help increase self-acceptance and reduce avoidance of cancer.
Category
Lifestyle

2

Description
Intervention group 2: They will receive group training on the Mindfulness-Based Interoceptive Exposure Task [MIET] through 6 120-minute sessions. The content of the intervention is: explaining the logic of the treatment, teaching concentration techniques, breathing meditation, sensory meditation and finally teaching the MIET technique in which the person pays attention to the pain in different parts of the body for 30 seconds and tries to accepts these pains and does not react to them and does not judge them.
Category
Behavior

3

Description
Control group: does not receive interference
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari Special and Subspecialty Clinic
Full name of responsible person
Fatemeh ghodosi
Street address
Shahid Motahari Special and Subspecialty Clinic., Namazi Hospital., KarimKhan Zand Ave., Namazi square., Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۷۱۴۷۳۷
Phone
+98 71 3212 7001
Email
motahari@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Amir Ghamarani
Street address
Faculty of Educational Sciences and Psychology., Azadi Square., Isfahan University., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 5502
Email
a.ghamarani@edu.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Isfahan
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
The University of Isfahan
Full name of responsible person
Mohsen Arefian
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology., Azadi Square., Isfahan University., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 5500
Email
m.arefian92@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shiraz
Full name of responsible person
Masoud Fadzalepour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology., Aram Ave., Shiraz University., Shiraz.
City
Shiraz
Province
Fars
Postal code
84759-71946
Phone
+98 71 3613 4670
Email
fazilat1348@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mohsen Arefian
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology., Azadi Square., Isfahan University., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 5500
Email
m.arefian92@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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