HopeNCT06465875
The Effect of Book Reading on Comfort, Hope, Anxiety and Vital Signs of Intensive Care Unit Patients
A study testing Reading a book in people with Hope and Comfort, run by TC Erciyes University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Reading a book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age,
- Stable clinical condition after intensive care unit admission,
- Have no physical or mental impairment in answering the questions,
- No verbal communication disability (hearing and speech),
- No diagnosed psychiatric disorder,
- With a Glasgow Coma Scale score of 15,
Show all 9Show fewer
- Not receiving sedation for at least 12 hours,
- Will be hospitalized for at least 3 days from the time of enrollment in the study,
- Individuals who agree to participate in the study will be included in the study.
Who cannot join
- People with hearing or vision problems,
- Intubated,
- Any diagnosed neurological or psychological disorder,
- Transferred to another unit or exitus before the specified period,
- Individuals who do not agree to participate in the study will not be included in the study.
About this study
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.
- Conditions
- Hope, Comfort, Anxiety, Vital Signs
- Being tested
- Reading a book
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading a bookOther
Individuals in the intervention group will be read a storybook for three nights.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will be read a storybook for three nights outside the routine practices of the clinic. Receives: Other: Reading a book |
| Control group | No intervention | The control group will not be subjected to any practice other than the routine practices of the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After reading the book of the 3rd day
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.
Measured: After reading the book of the 3rd day
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.
Measured: After reading the book of the 3rd day
Secondary outcomes (4)
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.
Measured: After reading the book of the 3rd day
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.
Measured: After reading the book of the 3rd day
Oxygen saturation to be assessed with Pulse Oximeter
Oxygen saturation from the finger will be measured and recorded with a Pulse Oximeter.
Measured: After reading the book of the 3rd day
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.
Measured: After reading the book of the 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HopeStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465875
- Sponsor's protocol ID
- 2024/147
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Book Reading on Comfort, Hope, Anxiety and Vital Signs of Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT06465875
- Acronym / sponsor ID
- 2024/147
- Conditions
- Hope, Comfort, Anxiety, Vital Signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jun 2024 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Reading a bookThe intervention group will be read a storybook for three nights outside the routine practices of the clinic. |
| Control group | No intervention | –The control group will not be subjected to any practice other than the routine practices of the clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 18 years of age,
- Stable clinical condition after intensive care unit admission,
- Have no physical or mental impairment in answering the questions,
- No verbal communication disability (hearing and speech),
- No diagnosed psychiatric disorder,
Key exclusion criteria (5 listed)
- People with hearing or vision problems,
- Intubated,
- Any diagnosed neurological or psychological disorder,
- Transferred to another unit or exitus before the specified period,
- Individuals who do not agree to participate in the study will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading a bookIndividuals in the intervention group will be read a storybook for three nights. | Other | Intervention group |
Primary outcome
Comfort level to be evaluated with the General Comfort Scale
Time frame: After reading the book of the 3rd day
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.
Level of hope to be assessed with the Dispositional Hope Scale
Time frame: After reading the book of the 3rd day
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.
Anxiety level to be assessed with State-Trait Anxiety Inventory
Time frame: After reading the book of the 3rd day
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.
4 secondary outcomes
Blood pressure to be assessed with monitor
Time frame: After reading the book of the 3rd day
Pulse to be assessed with monitor
Time frame: After reading the book of the 3rd day
Oxygen saturation to be assessed with Pulse Oximeter
Time frame: After reading the book of the 3rd day
Pain to be assessed with Numeric Rating Scale
Time frame: After reading the book of the 3rd day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Reading a book in people with Hope and Comfort, run by TC Erciyes University.
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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Comfort level to be evaluated with the General Comfort Scale (time frame: After reading the book of the 3rd day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2024.