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Not yet recruitingNCT06465875Updated Jun 20, 2024

The Effect of Book Reading on Comfort, Hope, Anxiety and Vital Signs of Intensive Care Unit Patients

An interventional study of Reading a book in Hope, Comfort and Anxiety, sponsored by TC Erciyes University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form.

Read the detailed description

This study was planned to investigate the effect of reading aloud books on comfort, hope, anxiety and vital signs in patients hospitalized in intensive care unit. This study was designed as a randomized controlled clinical trial. Data will be collected by using the Descriptive Characteristics Questionnaire, General Comfort Scale, Dispositional Hope Scale, State-Trait Anxiety Inventory, and the Vital Signs Monitoring Form. Individuals in the intervention group will be read a storybook for 3 nights in the intensive care unit. The control group will not be subjected to any practice other than the routine practices of the clinic.

02

Conditions studied

  • Hope
  • Comfort
  • Anxiety
  • Vital Signs

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 70 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

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Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Over 18 years of age,
  2. Stable clinical condition after intensive care unit admission,
  3. Have no physical or mental impairment in answering the questions,
  4. No verbal communication disability (hearing and speech),
  5. No diagnosed psychiatric disorder,
  6. With a Glasgow Coma Scale score of 15,
  7. Not receiving sedation for at least 12 hours,
  8. Will be hospitalized for at least 3 days from the time of enrollment in the study,
  9. Individuals who agree to participate in the study will be included in the study.

Exclusion criteria

Exclusion Criteria:

  1. People with hearing or vision problems,
  2. Intubated,
  3. Any diagnosed neurological or psychological disorder,
  4. Transferred to another unit or exitus before the specified period,
  5. Individuals who do not agree to participate in the study will not be included in the study.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Intervention group

    The intervention group will be read a storybook for three nights outside the routine practices of the clinic.

    Other: Reading a book

  • No intervention
    Control group

    The control group will not be subjected to any practice other than the routine practices of the clinic.

Interventions

  • OtherReading a book

    Individuals in the intervention group will be read a storybook for three nights.

06

What researchers measure

Primary outcomes

  1. Comfort level to be evaluated with the General Comfort Scale

    It was developed to assess the comfort level of patients. The scale consists of three levels: relief, relaxation and superiority and four dimensions: physical, psychospiritual, sociocultural and environmental.

    Time frame: After reading the book of the 3rd day

  2. Level of hope to be assessed with the Dispositional Hope Scale

    It was conducted to evaluate individuals' hope levels. It is an eight-point Likert type scale consisting of 12 items. Scores from the scale vary between 8 and 64.

    Time frame: After reading the book of the 3rd day

  3. Anxiety level to be assessed with State-Trait Anxiety Inventory

    The inventory was developed to determine the state and trait anxiety levels of individuals. The scale consists of 40 items in total. While the first 20 items measure the state anxiety level, the items from 21 to 40 measure the trait anxiety level of the individual. The total score value obtained from both parts varies between 20 and 80.

    Time frame: After reading the book of the 3rd day

Secondary outcomes

  1. Blood pressure to be assessed with monitor

    The patient's blood pressure will be measured from the brachial artery with a bedside monitor and the result will be recorded in mmHg.

    Time frame: After reading the book of the 3rd day

  2. Pulse to be assessed with monitor

    Heart rate will be measured with a bedside monitor that can be measured from a finger and recorded as beats/min.

    Time frame: After reading the book of the 3rd day

  3. Oxygen saturation to be assessed with Pulse Oximeter

    Oxygen saturation from the finger will be measured and recorded with a Pulse Oximeter.

    Time frame: After reading the book of the 3rd day

  4. Pain to be assessed with Numeric Rating Scale

    The number "0" on the scale means that they do not feel any pain and the number "10" refers to the worst pain.

    Time frame: After reading the book of the 3rd day

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06465875
Lead sponsor
TC Erciyes University
Responsible party
Sevda Korkut (Associate Prof., TC Erciyes University) — Principal investigator
First posted
Jun 20, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Oct 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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