Effect of Nature Based Sounds' Intervention on Agitation and Anxiety of Patients Admitted in Intensive Care Units.

Not Applicable

Completed

• Conditions: Agitated; State, Acute Reaction to Stress; Anxiety
• Interventions: Other: Nature based sounds

• Registration Number: NCT03213782
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

Brief Summary

Effect of nature based sounds' intervention on Agitation and Anxiety of patients admitted in Intensive Care Units of MMIMS\&R Hospital, Mullana, Ambala

Detailed Description

INTRODUCTION: Continue stay in ICU can lead to sleep disturbances and poor stress management that may result in client's inability to adjust with the situations and use of medical support. This experience may lead to increase agitation, anxiety as well as physiological stress of client, decrease comfort level and increase recovery time as well as hospital stay. There has been great emphasis on non-pharmacological methods that decrease anxiety and stress since they are very appropriate and affordable.

OBJECTIVES: The objective of the study was to assess the effect of Nature Based Sounds on Agitation and Anxiety of patients admitted in Intensive Care Units.

METHODOLOGY: A Randomized Controlled Trial with pretest posttest control group design was used. Sixty patients from Surgical Intensive care unit and were selected conveniently and randomly assigned into experimental and control group using lottery method. Data was collected by Agitation Behavior Assessment Scale and Beck Anxiety Inventory.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2017-01-07
• Study Completion: 2017-01-07
• Study First Submitted: 2017-06-27
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-08
• Last Update Submitted: 2017-07-08
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Willing to participate in the study.
2. In age group of 18 -75 years.

Exclusion Criteria

1. Patients who were not having agitated behavior, normal anxiety and normal physiologic stress scores.
2. Patients who were taking anti-hypertensive drugs, anti-depressants drugs and sedatives.
3. Who could not response verbally or non-verbally in response to Sample Characteristics Performa and Beck Anxiety Inventory.
4. Patients who were having psychiatric or neurological illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Nature based sounds	Nature based sounds are administered via head phones continuously for 20 minutes.

Primary Outcome Measures

Name	Time	Method
Agitation assessed with the Agitation Behavior Assessment Scale	8-10 minutes	Agitation Behavior Assessment Scale; A Score of 14 = absent: the behavior is not present.; 15-28= low degree.; 29-42= Moderate degree.; 43-56= Extreme degree.