NCT03213782

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

June 27, 2017

Last Update Submit

July 8, 2017

Conditions

Agitated; State, Acute Reaction to StressAnxiety

Keywords

Nature Based SoundsAgitationAnxietyPatientsIntensive Care Units

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: Nature based sounds

Control group

NO INTERVENTION

Usual routine care was continued

Interventions

Nature based soundsOTHER

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.

Experimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 14966671BACKGROUND

  • 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.

    PMID: 16236951BACKGROUND

  • 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.

    PMID: 24896278BACKGROUND

  • 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.

    PMID: 23245705RESULT

  • 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.

    PMID: 24035670RESULT

  • 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.

    PMID: 24079640RESULT

MeSH Terms

Conditions

Psychomotor AgitationStress Disorders, Traumatic, AcuteAnxiety Disorders

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Mrs. Vinay Kumari, Msc. Nursing

    MM University, Mullana, Ambala, Haryana, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 11, 2017

Study Start

August 1, 2015

Primary Completion

January 7, 2017

Study Completion

January 7, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share