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IRCT20240806062674N3 IRCT 2025-12-14 Shahre-kord University of Medical Sciences The effect of Betty Newman Model on death anxiety, fear of progression, and psychosocial adjustment to the disease in patients with Multiple Sclerosis The effect of Betty Newman System Model on death anxiety, fear of progression, and psychosocial adjustment to the disease in patients with Multiple Sclerosis 2025-12-31 anticipated 72 Complete https://irct.ir/trial/88083 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Multiple Sclerosis. Intervention 1: 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. Intervention 2: Control group: The control group will receive only routine care and education. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known.
public Farshad Heidari
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 Heidari.f@skums.ac.ir Shahre-kord University of Medical Sciences scientific Reheleh Javanbakhtian
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3333 0061 Rehelehjavanbakht@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 20 years no limit Both The presence of another incurable disease in addition to multiple sclerosis G35 Multiple sclerosis Behavior Behavior 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. Control group: The control group will receive only routine care and education. 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. 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. 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. Shahre-kord University of Medical Sciences Approved 2025-02-04 Research Ethics Committees of Shahrekord University of Medical Sciences Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)