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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213782
• Other study ID #: 200014
• Status: Completed
• Phase: N/A
• First received: June 27, 2017
• Last updated: July 8, 2017
• Start date: August 1, 2015
• Est. completion date: January 7, 2017

Study information

• Verified date: July 2017
• Source: Maharishi Markendeswar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 7, 2017
• Est. primary completion date: January 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitated; State, Acute Reaction to Stress
• Anxiety
• Anxiety Disorders
• Psychomotor Agitation
• Stress Disorders, Traumatic, Acute

Intervention

Other:
• Nature based sounds
Nature based sound was administered to the experimental group with head phones for continuously 20minutes. Posttest was done by continuously 30 minute observation after administration of nature based sound with the same tools.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

References & Publications (6)

Aghaie B, Rejeh N, Heravi-Karimooi M, Ebadi A, Moradian ST, Vaismoradi M, Jasper M. Effect of nature-based sound therapy on agitation and anxiety in coronary artery bypass graft patients during the weaning of mechanical ventilation: A randomised clinical — View Citation

Garland A, Olafson K, Ramsey CD, Yogendran M, Fransoo R. Epidemiology of critically ill patients in intensive care units: a population-based observational study. Crit Care. 2013 Sep 30;17(5):R212. doi: 10.1186/cc13026. — View Citation

Gullich I, Ramos AB, Zan TR, Scherer C, Mendoza-Sassi RA. Prevalence of anxiety in patients admitted to a university hospital in southern Brazil and associated factors. Rev Bras Epidemiol. 2013 Sep;16(3):644-57. English, Portuguese. — View Citation

Jaber S, Chanques G, Altairac C, Sebbane M, Vergne C, Perrigault PF, Eledjam JJ. A prospective study of agitation in a medical-surgical ICU: incidence, risk factors, and outcomes. Chest. 2005 Oct;128(4):2749-57. — View Citation

Saadatmand V, Rejeh N, Heravi-Karimooi M, Tadrisi SD, Zayeri F, Vaismoradi M, Jasper M. Effect of nature-based sounds' intervention on agitation, anxiety, and stress in patients under mechanical ventilator support: a randomised controlled trial. Int J Nur — View Citation

Woods JC, Mion LC, Connor JT, Viray F, Jahan L, Huber C, McHugh R, Gonzales JP, Stoller JK, Arroliga AC. Severe agitation among ventilated medical intensive care unit patients: frequency, characteristics and outcomes. Intensive Care Med. 2004 Jun;30(6):1066-72. Epub 2004 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agitation assessed with the Agitation Behavior Assessment Scale	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.	8-10 minutes