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

NCT ID: NCT03213782

Last Updated: 2017-07-11

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-01-07

Brief Summary

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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

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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.

Conditions

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Agitated; State, Acute Reaction to Stress Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

Nature based sounds

Intervention Type OTHER

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.

Control group

Usual routine care was continued

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role lead

Responsible Party

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Amandeep kaur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mrs. Vinay Kumari, Msc. Nursing

Role: STUDY_DIRECTOR

MM University, Mullana, Ambala, Haryana, India

References

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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. doi: 10.1007/s00134-004-2193-9. Epub 2004 Feb 14.

Reference Type BACKGROUND
PMID: 14966671 (View on PubMed)

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. doi: 10.1378/chest.128.4.2749.

Reference Type BACKGROUND
PMID: 16236951 (View on PubMed)

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. doi: 10.1590/s1415-790x2013000300009. English, Portuguese.

Reference Type BACKGROUND
PMID: 24896278 (View on PubMed)

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 Nurs Stud. 2013 Jul;50(7):895-904. doi: 10.1016/j.ijnurstu.2012.11.018. Epub 2012 Dec 14.

Reference Type RESULT
PMID: 23245705 (View on PubMed)

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 trial. Int J Nurs Stud. 2014 Apr;51(4):526-38. doi: 10.1016/j.ijnurstu.2013.08.003. Epub 2013 Aug 29.

Reference Type RESULT
PMID: 24035670 (View on PubMed)

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.

Reference Type RESULT
PMID: 24079640 (View on PubMed)

Other Identifiers

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200014

Identifier Type: -

Identifier Source: org_study_id

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