NCT07072078

Brief Summary

This study aims to evaluate the effectiveness of video-based communication in reducing loneliness among intensive care unit (ICU) patients at Dr. Hasan Sadikin General Hospital in Bandung, Indonesia. ICU patients often experience psychological distress, particularly loneliness, due to restricted family visits and physical isolation. A quasi-experimental design with a pre-test and post-test control group is used, involving 36 participants who are randomly assigned to either the intervention or control group. The intervention group receives structured video-based communication with family members for three consecutive days, with each session lasting between 5 to 20 minutes. Nurses facilitate the intervention by ensuring patient safety, providing emotional support, and assisting with the communication process. The control group receives standard ICU care without the communication intervention. Loneliness levels are assessed using the De Jong Gierveld Loneliness Scale (DJGLS) before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

June 29, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

LonelinessIntensive Care UnitVideo-based Communication

Outcome Measures

Primary Outcomes (1)

  • Change in Loneliness Score (De Jong Gierveld Loneliness Scale)

    This outcome measures the change in loneliness among ICU patients before and after the intervention, using the De Jong Gierveld Loneliness Scale (DJGLS). The scale assesses both emotional and social loneliness with 11 items, validated in Indonesian. Higher scores indicate greater loneliness. The score is recorded at baseline (pre-intervention) and after 3 days of intervention (post-test). The difference in mean scores is used to assess effectiveness.

    Baseline (Day 1) to Post-Intervention (Day 3)

Study Arms (2)

Intervention Group - Video-based Communication

EXPERIMENTAL

Participants in this group received structured video-based communication with their family members using WhatsApp. Each session lasted 5-20 minutes and was conducted once daily for three consecutive days. The communication was facilitated by a nurse and included positive messages, emotional support, and discussion of future plans. The aim was to reduce emotional and social loneliness in ICU patients.

Behavioral: Video-based Communication

Control Group - Standard ICU Care

NO INTERVENTION

Participants in this group received standard ICU care without any video-based communication intervention. They continued with routine treatment and monitoring in the ICU setting for the duration of the study period. This group was used as a comparison to assess the impact of video-based communication on loneliness levels.

Interventions

Participants received structured video-based communication sessions with their family members using the WhatsApp platform. The intervention was delivered once daily for three consecutive days, with each session lasting between 5 and 20 minutes. Communication was guided to include emotional support, positive conversations, and future-oriented discussion. The sessions were facilitated by nurses who ensured clinical stability, technical setup, and emotional readiness of the patient. This intervention aimed to reduce emotional and social loneliness among ICU patients and was integrated into standard intensive care routines without disrupting medical care.

Intervention Group - Video-based Communication

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted to the intensive care unit (ICU)
  • Patients aged over 18 years with a minimum of 72 hours of care in the ICU
  • Patients who are able to understand and communicate in the Indonesian language

You may not qualify if:

  • Patients with medical conditions such as decreased consciousness, total blindness, or severe neurological disorders
  • Patients with a history of psychiatric disorders
  • Drop Out:
  • Patients who are discharged from the ICU of Dr. Hasan Sadikin General Hospital during the study period will be considered drop-outs
  • Patients whose health deteriorates to the extent that they are unable to continue participation in the study
  • Patients who die during the study period
  • Patients who are transferred from the ICU to general inpatient wards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

dr. Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location

Study Officials

  • Cecep Eli Kosasih, S.Kp., MNS., Ph.D

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR
  • Ristina Mirwanti, S.Kep., Ners., M.Kep.

    Universitas Padjadjaran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This was an open-label study. No parties were masked. All participants, care providers, and investigators were aware of the group assignments and interventions being administered.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study used a parallel design with two groups: an intervention group and a control group. A total of 36 ICU patients were randomly assigned to each group (18 participants per group). The intervention group received video-based communication with family members once daily for three consecutive days, with each session lasting 5 to 20 minutes. The control group received standard ICU care without the intervention. Loneliness was measured in both groups using the De Jong Gierveld Loneliness Scale before and after the intervention. The study aimed to assess the effectiveness of video-based communication in reducing emotional and social loneliness among ICU patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 18, 2025

Study Start

December 24, 2024

Primary Completion

January 24, 2025

Study Completion

January 24, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations