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

NCT06465875 | Not Yet Recruiting

• 1 other identifier: 2024/147
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hope; Comfort; Anxiety; Vital Signs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Blood pressure to be assessed with monitor

  After reading the book of the 3rd day

• Pulse to be assessed with monitor

  After reading the book of the 3rd day

• Oxygen saturation to be assessed with Pulse Oximeter

  After reading the book of the 3rd day

• Pain to be assessed with Numeric Rating Scale

  After reading the book of the 3rd day

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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.

Interventions

Reading a book OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof.

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 20, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share