Protocol summary

Study aim
Determining the effect of Betty Newman's systemic model on death anxiety, fear of disease progression, and psychosocial adjustment to the disease in patients with multiple sclerosis.
Design
Randomized clinical trial with two control and experimental groups, with parallel groups, on 72 patients with Multiple Sclerosis, randomized using a four-size randomized block design.
Settings and conduct
MS Academic Committee affiliated with Shahrekord University of Medical Sciences and MS Association The control group will receive only routine training. In addition to routine care, the intervention group will receive a care program based on the Betty Newman nursing model. The intervention group will receive a program based on the Betty Newman model in 4 sessions, each session lasting 40 minutes, in groups (3 groups of 12 people) using educational videos, whiteboards and podcasts and lectures in the community and clinic environment to reduce the likelihood of encountering stressors or reducing reactions to stressors and strengthening flexible and natural defense lines with a focus on the nursing process.
Participants/Inclusion and exclusion criteria
1. Willingness to participate in the study and complete the informed consent form 2. Age 20 years and older 3. Definite diagnosis of multiple sclerosis in patients based on medical records 4. Being literate enough to read and write and understand the research questionnaire 5. Absence of other incurable diseases 6. EDSS criterion less than 4
Intervention groups
The intervention group will receive an educational intervention based on Betty Newman's systems model in four sessions, while the control group will only receive routine hospital education.
Main outcome variables
Death anxiety, Fear of disease progression, and Psychosocial adjustment to illness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240806062674N3
Registration date: 2025-12-14, 1404/09/23
Registration timing: prospective

Last update: 2025-12-14, 1404/09/23
Update count: 0
Registration date
2025-12-14, 1404/09/23
Registrant information
Name
Farshad Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
heidari.f@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-31, 1404/10/10
Expected recruitment end date
2026-07-01, 1405/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Betty Newman System Model on death anxiety, fear of progression, and psychosocial adjustment to the disease in patients with Multiple Sclerosis
Public title
The effect of Betty Newman Model on death anxiety, fear of progression, and psychosocial adjustment to the disease in patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1- Willingness to participate in the study and completing the informed consent form 2- At least 20 years old 3- Definite diagnosis of multiple sclerosis in patients based on medical records 4- Being literate enough to read and write and understand the questionnaire 5- EDSS criterion less than 4
Exclusion criteria:
The presence of another incurable disease in addition to multiple sclerosis
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment method of the samples to the groups was in the form of random blocks of four without permutation. For this purpose, first the letter A was considered for the control group and the letter B for the experimental group, and the different four-letter forms of the two groups (ABBA, ABAB, AABB, BAAB, BABA, BBAA) were written on six cards and placed in a sealed and opaque envelope. These envelopes were placed in a box, and the researcher did not know which group the units under study would be placed in until the card was selected. Then, the researcher determined which group the patients entering the study would be placed in by removing one of the envelopes from the box. This process continued until all the cards were removed from the bo,x and the cards were returned to the box again, and this random selection was repeated three times to provide the desired sample size.
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 Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2025-02-04, 1403/11/16
Ethics committee reference number
IR.SKUMS.REC.1403.133

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Score obtained from the Templer Death Anxiety Questionnaire
Timepoint
Before, immediately after and two months after the intervention
Method of measurement
Death anxiety will be measured by the Templer Death Anxiety Questionnaire. This questionnaire consists of 15 items that measure the subjects' attitudes in three components: death anxiety alone, general factor, fear of pain, and surgery. Subjects indicate their answers to each question with yes or no options, with scores of zero and one assigned to each item. Thus, the scores on this scale vary between 4 and 15. A high score (a score higher than "score 8") indicates high anxiety about death.

Secondary outcomes

1

Description
Score obtained from the Fear of Disease Progression Questionnaire by Hershbach et al.
Timepoint
Before, immediately after, and two months after the intervention
Method of measurement
Fear of disease progression will be measured by the Fear of Disease Progression Questionnaire by Hershbach et al. This questionnaire consisted of 13 items and had 5 subscales (emotional reaction, family, work, loss of independence, coping with anxiety). Responses to it include a Likert scale from 0 to 5 points from never to most of the time. The total score is calculated by summing the scores of the subscales except the coping subscale.

2

Description
Score obtained from the Drogatis Psychosocial Adjustment Questionnaire
Timepoint
Before, immediately after, and two months after the intervention
Method of measurement
Psychosocial adjustment to the disease will be measured by the Drugatis Psychosocial Adjustment to Disease Questionnaire. This questionnaire has 45 questions and seven subscales: attitude towards the disease (eight questions), work environment (six questions), family environment (eight questions), sexual relations (six questions), development of family relationships (five questions), social environment (six questions), and psychological disorders (seven questions). The scoring of this questionnaire is based on a four-choice Likert scale (not at all, sometimes, most of the time, and completely) from 0 to 3 for each question, and the total score of the test ranges from 0 to 135. The average adjustment score for each component is obtained from the sum of the scores for each component and divided by the number of questions in that component, and the average total adjustment score is obtained from the sum of the scores for all questions and divided by the number of questions. Higher scores indicate an inappropriate adjustment status. The total adjustment score is classified into three categories: high adjustment, moderate adjustment, and low adjustment.

Intervention groups

1

Description
Intervention group: First, the study questionnaires will be completed by all samples. After reviewing the scores of the questionnaires and determining the areas that received lower scores and needed more intervention, potential and actual stressors and intrapersonal, interpersonal, and created (transpersonal) factors will be determined by evaluating the 5 variables that make up the Betty Newman model (physiological-evolutionary-psychological-social, cultural-spiritual). Then, the intervention group will receive a program based on the Betty Newman model in 4 sessions, each session lasting 40 minutes, in groups (3 groups of 12 people) using educational videos, whiteboards, podcasts, and lectures in the community and clinic environment to reduce the likelihood of encountering stressors or reducing reactions to stressors and strengthening flexible and natural defense lines with a focus on the nursing process.
Category
Behavior

2

Description
Control group: The control group will receive only routine care and education.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahrekord MS Association
Full name of responsible person
Farshad heidari
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Farshad2862@gmail.com

2

Recruitment center
Name of recruitment center
MS Academic Committee
Full name of responsible person
Farshad Heidari
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Seyyed Mohammad Omrani
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Farshad Heidari
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reheleh Javanbakhtian
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Rehelehjavanbakht@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farshad Heidari
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir

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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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