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Clinical Trials/NCT03213782
NCT03213782CompletedNot Applicable

Effect of Nature Based Sounds' Intervention on Agitation and Anxiety of Patients Admitted in Intensive Care Units of MMIMS&R Hospital, Mullana, Ambala

Maharishi Markendeswar University (Deemed to be University)0 sites60 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Primary Endpoint
Agitation assessed with the Agitation Behavior Assessment Scale

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Experimental group

Experimental

Nature based sounds are administered via head phones continuously for 20 minutes.

Intervention: Nature based sounds (Other)

Control group

No Intervention

Usual routine care was continued

Outcomes

Primary Outcomes

Agitation assessed with the Agitation Behavior Assessment Scale

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Maharishi Markendeswar University (Deemed to be University)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amandeep kaur

Principal Investigator

Maharishi Markendeswar University (Deemed to be University)

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