The effect of written emotional disclosure on the care burden, anxiety and depression of the family caregivers of hemodialysis patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220315054296N1

Enrollment

Registered

2022-04-07

Start date

2022-04-30

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention 1: Intervention group: The first intervention group: After completing the initial questionnaires, the standard guidelines of written emotional disclosure based on the evidence-based writt

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Age 18 to 75 years old Providing care directly to the patient under hemodialysis at least in the past 3 months Speaking in Persian The ability to read and write in Persian Having physical and mental health necessary for caring role Consent to participate in the study Access to smartphone Ability to use smartphone

Exclusion criteria

Exclusion criteria: Simultaneous care of another patient with chronic illness

Design outcomes

Primary

Measure	Time frame
Anxiety score in Generalized Anxiety Disorder 7-item scale by Spitzer et al. Timepoint: Before and one month after the intervention. Method of measurement: Generalized Anxiety Disorder 7-item scale designed by Spitzer et al. It has 7 items, and an additional question that measures the interference of anxiety in individual, social, family and occupational functions. The subjects with choosing one of the options for no time, more than half of the days, and almost every day, answer questions, and options are graded with scores 1,0, 2 and 3, and thus the domain Scores are from 0 to 21. Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety, Score greater than 15: Severe Anxiety.;The symptoms of depression (not diagnosis of depression) with depression score in Beck Depression Inventory (II). Timepoint: Before and one month after the intervention. Method of measurement: In this study, the symptoms of depression are identified (not diagnosis of depression), which is determined by the calculated score of the participants' response to the Beck Depression Inventory(II), which is a self-reporting tool for measuring the severity of depression. The overall score is in the range of 0 to 63, with a score of 0 to 13 no or low depression, 14 to 19 mild depression, 20 to 28 moderate depression and 29 to 63 severe depression.;Care burden score in Caregiver Burden Inventory by Novak & Guest. Timepoint: Before and one month after the intervention. Method of measurement: 24-item multi-dimensional questionnaire measuring caregiver burden with 5 subscales: Time Dependence; Developmental; Physical Burden; Social Burden; Emotional Burden. Scores for each item are evaluated using a 5-point Likert scale ranging from 0 (not at all disruptive) to 4 (very disruptive). The scores are variable from 0 to 96 and a higher score indicates a higher care burden.	—

Measure

Time frame

Anxiety score in Generalized Anxiety Disorder 7-item scale by Spitzer et al. Timepoint: Before and one month after the intervention. Method of measurement: Generalized Anxiety Disorder 7-item scale designed by Spitzer et al. It has 7 items, and an additional question that measures the interference of anxiety in individual, social, family and occupational functions. The subjects with choosing one of the options for no time, more than half of the days, and almost every day, answer questions, and options are graded with scores 1,0, 2 and 3, and thus the domain Scores are from 0 to 21. Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety, Score greater than 15: Severe Anxiety.;The symptoms of depression (not diagnosis of depression) with depression score in Beck Depression Inventory (II). Timepoint: Before and one month after the intervention. Method of measurement: In this study, the symptoms of depression are identified (not diagnosis of depression), which is determined by the calculated score of the participants' response to the Beck Depression Inventory(II), which is a self-reporting tool for measuring the severity of depression. The overall score is in the range of 0 to 63, with a score of 0 to 13 no or low depression, 14 to 19 mild depression, 20 to 28 moderate depression and 29 to 63 severe depression.;Care burden score in Caregiver Burden Inventory by Novak & Guest. Timepoint: Before and one month after the intervention. Method of measurement: 24-item multi-dimensional questionnaire measuring caregiver burden with 5 subscales: Time Dependence; Developmental; Physical Burden; Social Burden; Emotional Burden. Scores for each item are evaluated using a 5-point Likert scale ranging from 0 (not at all disruptive) to 4 (very disruptive). The scores are variable from 0 to 96 and a higher score indicates a higher care burden.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Lotfolahi

Tehran University of Medical Sciences

zahra.ltf1998@gmail.com+98 21 6691 4368

Outcome results