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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Comfort; Vital Signs; Hope
• Intervention / Treatment: Other: Reading a book

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Individuals in the intervention group will be read a storybook for three nights.
No Intervention: Control group; The control group will not be subjected to any practice other than the routine practices of the clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	After reading the book of the 3rd day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	After reading the book of the 3rd day

Collaborators and Investigators

• Sponsor: TC Erciyes University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Estimated): June 19, 2024

Study Record Updates

• Last Update Posted (Estimated): June 19, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2024/147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No