NCT06835673

Brief Summary

a prospective observational study conducted in ICU of tertiary hospital under the guidance of mentors of department of critical care medicine TUTH to identify the Prevalence of Anxiety and Depression Among Family Members of ICU Patients in a Tertiary-Level Hospital in Nepal

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 14, 2025

Last Update Submit

February 14, 2025

Conditions

Keywords

anxiety and depressionFAMILY MEMBERSCRITICALLY ILLICUHADS

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Anxiety and Depression Among Family Members of ICU Patients in a Tertiary-Level Hospital in Nepal

    caretaker visitors of the critically ill patients admitted in ICU of TUTH were interviewed using a validated score HADS to see the prevalence of anxiety and depression amongst them.

    4 months

Study Arms (1)

interview of caretaker/ visitors of the patients who are admitted to the ICU for more than 48 hours

a validated tool of anxiety and depression HADS ( HOSPITAL ANXIETY AND DEPRESSION SCORE) used in a structured way to interview the caretaker/visitors of the critically ill patients admitted in ICU

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Family members aged 18 and above Family members of patients who have been admitted to the ICU for more than 48 hours.

You may qualify if:

  • Family members aged 18 and above Family members of patients who have been admitted to the ICU for more than 48 hours.

You may not qualify if:

  • Family members who refuse to give consent. Unable to understand Nepali language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUTH

Kathmandu, Nepal

Location

Related Publications (6)

  • Gurbuz H, Demir N. Anxiety and Depression Symptoms of Family Members of Intensive Care Unit Patients: A Prospective Observational Study and the Lived Experiences of the Family Members. Avicenna J Med. 2023 Jun 16;13(2):89-96. doi: 10.1055/s-0043-1769933. eCollection 2023 Apr.

    PMID: 37435558BACKGROUND
  • Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7. doi: 10.1097/00003246-200110000-00007.

    PMID: 11588447BACKGROUND
  • Kulkarni HS, Kulkarni KR, Mallampalli A, Parkar SR, Karnad DR, Guntupalli KK. Comparison of anxiety, depression, and post-traumatic stress symptoms in relatives of ICU patients in an American and an Indian public hospital. Indian J Crit Care Med. 2011 Jul;15(3):147-56. doi: 10.4103/0972-5229.84891.

    PMID: 22013306BACKGROUND
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND
  • Risal A, Manandhar K, Linde M, Koju R, Steiner TJ, Holen A. Reliability and Validity of a Nepali-language Version of the Hospital Anxiety and Depression Scale (HADS). Kathmandu Univ Med J (KUMJ). 2015 Apr-Jun;13(50):115-24. doi: 10.3126/kumj.v13i2.16783.

    PMID: 26657079BACKGROUND
  • Bialek K, Sadowski M. Stress, anxiety, depression and basic hope in family members of patients hospitalised in intensive care units - preliminary report. Anaesthesiol Intensive Ther. 2021;53(2):134-140. doi: 10.5114/ait.2021.105728.

    PMID: 34006051BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionCritical Illness

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

August 1, 2024

Primary Completion

November 22, 2024

Study Completion

November 22, 2024

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

supplementary tables will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
once the study is published
Access Criteria
open

Locations