Anxiety Disorder/Anxiety StateHADSNCT06835673
The ICU is a Complex Setting Where Critically Ill Patients Are Treated, Impacting Caregivers' Mental Health, Leading to Anxiety and Depression .we Aim to Identify the Prevalence of Anxiety and Depression Among Family Members of ICU Patients in a Tertiary-Level Hospital in Nepal
An observational study of Anxiety Disorder/Anxiety State, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder/Anxiety State
- How many people
- 110 participants
- Where
- 1 siteNepal
- Study dates
- 1 Aug 2024to 22 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Family members aged 18 and above Family members of patients who have been admitted to the ICU for more than 48 hours.
Who may be able to join
- Family members aged 18 and above Family members of patients who have been admitted to the ICU for more than 48 hours.
- -
Who cannot join
- Family members who refuse to give consent. Unable to understand Nepali language.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREVALENCE OF ANXIETY AND DEPRESSION AMONG FAMILY MEMBERS OF ICU PATIENTS IN A TERTIARY-LEVEL HOSPITAL IN NEPAL: A PROSPECTIVE OBSERVATIONAL STUDY
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
Read the detailed description
Rationale:
The Intensive Care Unit (ICU) is a demanding environment designed to care for critically ill patients requiring constant medical attention and specialized resources. Admission to the ICU is extremely stressful for both patients and their families, leading to considerable physical and mental stress which can manifests as anxiety and depression. Understanding the prevalence of these conditions and their association with unmet needs is crucial for developing targeted interventions.
Study objective:
Design: A prospective cross sectional descriptive study design Duration: August-Nov 2024 Place: Intensive care units (ICUs) of the Department of Critical Care Medicine, Tribhuvan University Teaching Hospital (TUTH) and Intensive care units (ICUs) of MMC
Introduction The Intensive Care Unit (ICU) is a critical care environment designed to provide continuous and intensive medical attention to patients with severe and life-threatening conditions. The complex medical interventions and the high-stress environment within the ICU have significant psychological impacts not only on the patients but also on their family members. The emotional burden experienced by relatives during a loved one's ICU stay is profound and often manifests as anxiety and depression.
Relatives of ICU patients frequently report high levels of stress, anxiety, and depression due to the uncertain prognosis and the intimidating ICU environment. Despite the recognition of these emotional challenges, there is a lack of comprehensive studies that quantify the prevalence of anxiety and depression among family members and correlate these conditions with their unmet needs during the ICU stay. Addressing these gaps is essential for developing effective support strategies.
Study variables Baseline characteristics Age Gender Diagnosis Marital status APACHE II score Calculated mortality rate Illness (acute or chronic) Planned / unplanned admission Admission from ED/ ward Interventions done to the patients Intubation and mechanical ventilation Hemodialysis catheter / CRRT Chest tube insertion Foley's catheterization Nasogastric tube insertion Central line insertion Surgical drain Restraints Tracheostomy
Visitor Baseline Characteristics:
Gender Age Education Marital status Relationship with the patient Previous ICU hospitalizations in the family Residence with the patient Number of visits per day Occupation status
Expected time and duration of the study Sample size of 110 will be collected.
Tools and techniques for data collection The tools that will be used in this study include The Hospital Anxiety and Depression Scale (HADS), modified in the Nepali version All data will be recorded using pre-formed proformas.
Management protocol of patients/participants Family members of all adult patients who are equal to or >18 years of age will be included in the study.
Patients should be admitted in the ICU for at least 48 hours. Visitors who are next to the kin ( nearest ) care taker will be chosen for the interview.
As a routine care of the ICU ,family members have fixed visiting hours in the ICU.
The one to be interviewed will have to visit the ICU and his admitted family member at least once in these 48 hours.
Also, as routine care Family members of the admitted patients are counselled by the doctors on duty at least once a day regarding the ware bouts of the patients and further if required.
Family members are also counselled by the assigned bed side nurse of the patient about the visiting hours and orientation regarding ICU rules and requirements.
Family members who have visited his patient once and who has been once counselled by the assigned nurse and the duty doctor at least once will be interviewed by the interviewer.
Interview can be taken at any time of the day as per the convenience or the member for interview or the interviewer.
Patients' demographics and baseline characteristics will be taken from the ICU data.
The tubes and catheters that the patients had during the family member's visit were recorded to detect how these interventions affected the family member's mood state APACHE 2 score will be calculated of the 1st 24 hours of admission. An informed written consent will be obtained from the interviewee before the commencement of the interview.
Family member's characteristics will be obtained by the interview. HADS questionnaire will be used as the tool for assessing the anxiety and depression amongst family members.
Family member will be given the option of either self-assessing the questionnaire or if not able to read and write will be directed by the interviewer himself/ herself by reading out the questionnaire.
HADS questionnaires is attached at the end of the proforma. No cameras , voice tape or video will be recorded. Baseline characteristics Age Gender Diagnosis Marital status APACHE II score Calculated mortality rate Illness (acute or chronic) Planned / unplanned admission Admission from ED/ ward Interventions done to the patients Intubation and mechanical ventilation Hemodialysis catheter / CRRT Chest tube insertion Foley's catheterization Nasogastric tube insertion Central line insertion Surgical drain Restraints Tracheostomy
Visitor Baseline Characteristics:
Gender Age Education Marital status Relationship with the patient Previous ICU hospitalizations in the family Day of hospitalization Residence with the patient Number of visits per day Occupation status
- Conditions
- Anxiety Disorder/Anxiety State
- Keywords
- anxiety and depression, FAMILY MEMBERS, CRITICALLY ILL, ICU, HADS
- Medical subject headings
- Anxiety Disorders, Depression, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Aug 2024
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorder/Anxiety StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadikshya Regmi, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835673
- Sponsor's protocol ID
- 202(6-11)E2
- Other IDs
- PROFF DR BISHWAS PRADHAN
- Acronym
- HADS
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: supplementary tables will be shared
Publications
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.
PubMed 37435558Pochard 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.
PubMed 11588447Kulkarni 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.
PubMed 22013306Zigmond 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.
PubMed 6880820Risal 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.
PubMed 26657079Bialek 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.
PubMed 34006051
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE OF ANXIETY AND DEPRESSION AMONG FAMILY MEMBERS OF ICU PATIENTS IN A TERTIARY-LEVEL HOSPITAL IN NEPAL: A PROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT06835673
- Acronym / sponsor ID
- HADS / 202(6-11)E2
- Conditions
- Anxiety Disorder/Anxiety State
- Keywords
- anxiety and depression, FAMILY MEMBERS, CRITICALLY ILL, ICU, HADS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Rationale:
The Intensive Care Unit (ICU) is a demanding environment designed to care for critically ill patients requiring constant medical attention and specialized resources. Admission to the ICU is extremely stressful for both patients and their families, leading to considerable physical and mental stress which can manifests as anxiety and depression. Understanding the prevalence of these conditions and their association with unmet needs is crucial for developing targeted interventions.
Study objective:
Design: A prospective cross sectional descriptive study design Duration: August-Nov 2024 Place: Intensive care units (ICUs) of the Department of Critical Care Medicine, Tribhuvan University Teaching Hospital (TUTH) and Intensive care units (ICUs) of MMC
Introduction The Intensive Care Unit (ICU) is a critical care environment designed to provide continuous and intensive medical attention to patients with severe and life-threatening conditions. The complex medical interventions and the high-stress environment within the ICU have significant psychological impacts not only on the patients but also on their family members. The emotional burden experienced by relatives during a loved one's ICU stay is profound and often manifests as anxiety and depression.
Relatives of ICU patients frequently report high levels of stress, anxiety, and depression due to the uncertain prognosis and the intimidating ICU environment. Despite the recognition of these emotional challenges, there is a lack of comprehensive studies that quantify the prevalence of anxiety and depression among family members and correlate these conditions with their unmet needs during the ICU stay. Addressing these gaps is essential for developing effective support strategies.
Study variables Baseline characteristics Age Gender Diagnosis Marital status APACHE II score Calculated mortality rate Illness (acute or chronic) Planned / unplanned admission Admission from ED/ ward Interventions done to the patients Intubation and mechanical ventilation Hemodialysis catheter / CRRT Chest tube insertion Foley's catheterization Nasogastric tube insertion Central line insertion Surgical drain Restraints Tracheostomy
Visitor Baseline Characteristics:
Gender Age Education Marital status Relationship with the patient Previous ICU hospitalizations in the family Residence with the patient Number of visits per day Occupation status
Expected time and duration of the study Sample size of 110 will be collected.
Tools and techniques for data collection The tools that will be used in this study include The Hospital Anxiety and Depression Scale (HADS), modified in the Nepali version All data will be recorded using pre-formed proformas.
Management protocol of patients/participants Family members of all adult patients who are equal to or >18 years of age will be included in the study.
Patients should be admitted in the ICU for at least 48 hours. Visitors who are next to the kin ( nearest ) care taker will be chosen for the interview.
As a routine care of the ICU ,family members have fixed visiting hours in the ICU.
The one to be interviewed will have to visit the ICU and his admitted family member at least once in these 48 hours.
Also, as routine care Family members of the admitted patients are counselled by the doctors on duty at least once a day regarding the ware bouts of the patients and further if required.
Family members are also counselled by the assigned bed side nurse of the patient about the visiting hours and orientation regarding ICU rules and requirements.
Family members who have visited his patient once and who has been once counselled by the assigned nurse and the duty doctor at least once will be interviewed by the interviewer.
Interview can be taken at any time of the day as per the convenience or the member for interview or the interviewer.
Patients' demographics and baseline characteristics will be taken from the ICU data.
The tubes and catheters that the patients had during the family member's visit were recorded to detect how these interventions affected the family member's mood state APACHE 2 score will be calculated of the 1st 24 hours of admission. An informed written consent will be obtained from the interviewee before the commencement of the interview.
Family member's characteristics will be obtained by the interview. HADS questionnaire will be used as the tool for assessing the anxiety and depression amongst family members.
Family member will be given the option of either self-assessing the questionnaire or if not able to read and write will be directed by the interviewer himself/ herself by reading out the questionnaire.
HADS questionnaires is attached at the end of the proforma. No cameras , voice tape or video will be recorded. Baseline characteristics Age Gender Diagnosis Marital status APACHE II score Calculated mortality rate Illness (acute or chronic) Planned / unplanned admission Admission from ED/ ward Interventions done to the patients Intubation and mechanical ventilation Hemodialysis catheter / CRRT Chest tube insertion Foley's catheterization Nasogastric tube insertion Central line insertion Surgical drain Restraints Tracheostomy
Visitor Baseline Characteristics:
Gender Age Education Marital status Relationship with the patient Previous ICU hospitalizations in the family Day of hospitalization Residence with the patient Number of visits per day Occupation status
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Family members aged 18 and above Family members of patients who have been admitted to the ICU for more than 48 hours.
Key inclusion criteria (2 listed)
- Family members aged 18 and above Family members of patients who have been admitted to the ICU for more than 48 hours.
- -
Key exclusion criteria (2 listed)
- Family members who refuse to give consent. Unable to understand Nepali language.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Anxiety and Depression Among Family Members of ICU Patients in a Tertiary-Level Hospital in Nepal
Time frame: 4 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Background: PubMed 37435558Gurbuz 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.
- Background: PubMed 11588447Pochard 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.
- Background: PubMed 22013306Kulkarni 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.
- Background: PubMed 6880820Zigmond 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.
- Background: PubMed 26657079Risal 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.
- Background: PubMed 34006051Bialek 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.
- Individual participant dataSharing planned: Yes. supplementary tables will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorder/Anxiety State, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Anxiety and Depression Among Family Members of ICU Patients in a Tertiary-Level Hospital in Nepal (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835673, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.