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Comparison of the effectiveness of compassion-based hypnotherapy and Acceptance and commitment therapy on pain intensity, depression symptoms and sleep quality in patients with breast cancer

Protocol summary

Study aim
This study aimed to compare two methods of compassion-based hypnotherapy and Acceptance & commitment therapy on pain intensity, depression symptoms, and sleep quality in patients with breast cancer in Yasuj.
Design
The present study is a randomized clinical trial in which a pre-test and post-test design with two experimental groups and two control groups will be used Independent variable (1X): compassion-based hypnotherapy Independent variable (2X): Acceptance & commitment therapy Pre-test (T1): Test for pain intensity, depression symptoms, and sleep quality Post-test (T2): Test for pain intensity, depression symptoms and sleep quality
Settings and conduct
The present study is a clinical trial with pre-test and post-test design with two experimental groups and a control group. Among breast cancer patients referred to Yasuj Cancer Clinic, the samples that meet the inclusion criteria will be randomly assigned to two experimental (30 patients) and one control group (30 patients).
Participants/Inclusion and exclusion criteria
The inclusion criteria are: Women diagnosed with breast cancer, according to oncologist and paraclinical findings, passing at least 6 months after diagnosis, lack of physical and mental disability that prevents patients from attending therapy sessions, and having symptoms of moderate or severe depression. Exclusion criteria Absence from group therapy sessions for more than two sessions and unwillingness to continue the therapy, migration, or death of patients. .
Intervention groups
(1X): Compassion-based hypnotherapy (2X): Acceptance and commitment therapy
Main outcome variables
Independent variable : compassion-based Hypnotherapy Independent variable : Acceptance & commitment therapy Pre-test : pain intensity, depression symptoms, and sleep quality Post-test : pain intensity, depression symptoms, and sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220214054018N1
Registration date: 2022-04-27, 1401/02/07
Registration timing: prospective

Last update: 2022-04-27, 1401/02/07
Update count: 0
Registration date
2022-04-27, 1401/02/07
Registrant information
Name
Mohammadali Javid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 0790
Email address
mohamadalijavid1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of compassion-based hypnotherapy and Acceptance and commitment therapy on pain intensity, depression symptoms and sleep quality in patients with breast cancer
Public title
The effectiveness of hypnotherapy and acceptance and commitment therapy on pain intensity, depressive symptoms, and sleep quality.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women diagnosed with breast cancer, according to oncologist and paraclinical findings, passing at least 6 months after diagnosis, lack of physical and mental disability that prevents patients from attending therapy sessions, having symptoms of mild depression, and not attending mental courses at the same time.
Exclusion criteria:
Absence from group therapy sessions for more than two sessions and unwillingness to continue the therapy, migration, or death of patients.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a clinical trial with pre-test, post-test, and two experimental and one control group. The statistical population of the study will include all breast cancer patients referred to Yasuj Cancer Clinic in 2022. Then, 90 patients who meet the inclusion criteria will be selected and randomly assigned to study groups using a random number table. Then, 90 patients who meet the inclusion criteria will be selected and in order to ensure that an equal number of participants will enter the intervention and control groups, the research samples will be assigned to one of the three study groups using blocked random assignment (blocks of 3, 6 and 9 people).
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients receive therapeutic interventions, but they don't know what group they are in.
Placebo
Not used
Assignment
Other
Other design features
Psychological intervention and treatment techniques

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Islamic Azad University - Yasouj Branch
Street address
First Unit., Sina Building, , Pezeshk Alley, Motahhari St Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591784868
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.IAU.YASOOJ.REC.1400.005

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

2

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Pain intensity, depression symptoms and sleep quality
Timepoint
Ninety days
Method of measurement
Questionnaire and interview

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Compassion-based hypnotherapy
Category
Behavior

2

Description
Intervention Group: Acceptance and Commitment Therapy
Category
Behavior

3

Description
Control group: without intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajaei Hospital in Yasuj (Cancer clinic)
Full name of responsible person
Mohammadali Javid
Street address
First Unit., Sina Building, , Pezeshk Alley, Motahhari St Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591784868
Phone
+98 74 3323 0790
Email
mohamadalijavid1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj Islamic Azad University
Full name of responsible person
Mohammadali Javid
Street address
First Unit., Sina Building, , Pezeshk Alley, Motahhari St Yasuj
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591784868
Phone
+98 74 3323 0790
Email
mohamadalijavid1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj Islamic Azad University and Yasuj University of Medical Sciences
Proportion provided by this source
20
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
Islamic Azad University
Full name of responsible person
Mohammad ali javid
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
First Unit., Sina Building, , Pezeshk Alley, Motahhari St Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591784868
Phone
+98 74 3323 0790
Email
mohamadalijavid1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammadali Javid
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
First Unit., Sina Building, , Pezeshk Alley, Motahhari St Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591784868
Phone
+98 74 3323 0790
Email
mohamadalijavid1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamadali Javid
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
First Unit., Sina Building, , Pezeshk Alley, Motahhari St Yasuj
City
Yasuoj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591784868
Phone
+98 74 3323 0790
Fax
Email
mohamadalijavid1@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The research paper will be uploaded on the site.
When the data will become available and for how long
From March 2022 to September 2023
To whom data/document is available
Researchers and patients with breast cancer
Under which criteria data/document could be used
Psychotherapy, research, and education
From where data/document is obtainable
Researcher, Yasouj Islamic Azad University, and the journal in which the article will be published.
What processes are involved for a request to access data/document
The process of intervention, data collection, and data analysis will take 6 months.
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