The Effect of Eye Mask and Music on Sleep Quality and Delirium in Patients Monitored in Intensive Care Unit

NCT ID: NCT06268158

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-04-01

Brief Summary

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After abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. Postoperative delirium (POD) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. Effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. This study conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit.

It was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.Considering possible sample loss, the study was completed with 45 patients, 21 in the experimental group and 24 in the control group.

During the data collection phase, the Patient Information Form, Richard-Campbell Sleep Scale, Nursing Delirium Screening Scale and Richmond Agitation-Sedation Scale, were used.

Detailed Description

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Conditions

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Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

Patients in the experimental group will wear an eye patch after 22:00, when clinical interventions are less frequent, and will be listened to calming music once a day for 1 hour for 3 days.

Group Type EXPERIMENTAL

Eye patch

Intervention Type BEHAVIORAL

The experimental group will fill out the patient introduction form, Richmond Agitation-Sedation Scale, Nursing Delirium Screening Scale and Richard-Campbell Sleep Scale on the first day. On the 4th day of the study, the Nursing Delirium Screening Scale and the Richard-Campbell Sleep Scale will be completed.

Control group

No treatment will be performed on patients in the control group outside of their clinical routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eye patch

The experimental group will fill out the patient introduction form, Richmond Agitation-Sedation Scale, Nursing Delirium Screening Scale and Richard-Campbell Sleep Scale on the first day. On the 4th day of the study, the Nursing Delirium Screening Scale and the Richard-Campbell Sleep Scale will be completed.

Intervention Type BEHAVIORAL

Other Intervention Names

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Music

Eligibility Criteria

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Inclusion Criteria

* Those who have had abdominal surgery
* Those who volunteer to participate in the research
* Those who are over 18 years old
* Richmond Agitation-Sedation Scale -1, 0, +1
* Those who have been in intensive care for at least 3 days
* No communication problems (language, hearing impairment, etc.)
* No mental problems
* Patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study.

Exclusion Criteria

* Those who experience blood loss and fluid electrolyte imbalance after surgery
* There are contraindications to the use of eye masks (for example, head trauma),
* Patients with delirium before or after surgery will not be included in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Yeliz Sürme

Assoc.Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeliz Sürme, PhD

Role: PRINCIPAL_INVESTIGATOR

TC Erciyes University

Locations

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Erciyes University

Kayseri, Talas, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Puppo Moreno AM, Abella Alvarez A, Morales Conde S, Perez Flecha M, Garcia Urena MA. The intensive care unit in the postoperative period of major abdominal surgery. Med Intensiva (Engl Ed). 2019 Dec;43(9):569-577. doi: 10.1016/j.medin.2019.05.007. Epub 2019 Aug 1. English, Spanish.

Reference Type BACKGROUND
PMID: 31377023 (View on PubMed)

Linke GR, Mieth M, Hofer S, Trierweiler-Hauke B, Weitz J, Martin E, Buchler MW. Surgical intensive care unit - essential for good outcome in major abdominal surgery? Langenbecks Arch Surg. 2011 Apr;396(4):417-28. doi: 10.1007/s00423-011-0758-y. Epub 2011 Mar 3.

Reference Type BACKGROUND
PMID: 21369847 (View on PubMed)

Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

Reference Type BACKGROUND
PMID: 12421743 (View on PubMed)

Other Identifiers

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2023/45

Identifier Type: -

Identifier Source: org_study_id

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