NCT06900504

Brief Summary

The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group. Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients. H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
1mo left

Started Jun 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress93%
Jun 2025May 2026

First Submitted

Initial submission to the registry

March 23, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 23, 2025

Last Update Submit

March 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital-acquired insomnia

    Insomnia Score Average

    1 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Sleep hygiene education will be given to the experimental group.

Other: Sleep hygiene education

Control Group

NO INTERVENTION

Standard application procedure will be applied to the control group.

Interventions

A structured training booklet will be prepared to ensure sleep hygiene for individuals. In addition, sleep hygiene training will be provided to individuals.

Experimental Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old
  • Being literate
  • Being a heart failure patient
  • Being hospitalized for at least 1 week and staying for another week
  • Not having a condition that prevents verbal communication
  • Not having a diagnosed psychiatric problem
  • Being a volunteer to participate in the research

You may not qualify if:

  • Having a verbal communication disability
  • Having a diagnosed psychiatric problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Research Hospital

Erzurum, 04100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 28, 2025

Study Start

June 30, 2025

Primary Completion

November 30, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations