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

Primary Purpose

Agitated; State, Acute Reaction to Stress, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nature based sounds
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitated; State, Acute Reaction to Stress focused on measuring Nature Based Sounds, Agitation, Anxiety, Patients, Intensive Care Units

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group

    Control group

    Arm Description

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

    Usual routine care was continued

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 27, 2017
    Last Updated
    July 8, 2017
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03213782
    Brief Title
    Effect of Nature Based Sounds' Intervention on Agitation and Anxiety of Patients Admitted in Intensive Care Units.
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2015 (Actual)
    Primary Completion Date
    January 7, 2017 (Actual)
    Study Completion Date
    January 7, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be University)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Agitated; State, Acute Reaction to Stress, Anxiety
    Keywords
    Nature Based Sounds, Agitation, Anxiety, Patients, Intensive Care Units

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Nature based sounds are administered via head phones continuously for 20 minutes.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Usual routine care was continued
    Intervention Type
    Other
    Intervention Name(s)
    Nature based sounds
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Agitation assessed with the Agitation Behavior Assessment Scale
    Description
    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.
    Time Frame
    8-10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mrs. Vinay Kumari, Msc. Nursing
    Organizational Affiliation
    MM University, Mullana, Ambala, Haryana, India
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    14966671
    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. doi: 10.1007/s00134-004-2193-9. Epub 2004 Feb 14.
    Results Reference
    background
    PubMed Identifier
    16236951
    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. doi: 10.1378/chest.128.4.2749.
    Results Reference
    background
    PubMed Identifier
    24896278
    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. doi: 10.1590/s1415-790x2013000300009. English, Portuguese.
    Results Reference
    background
    PubMed Identifier
    23245705
    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 Nurs Stud. 2013 Jul;50(7):895-904. doi: 10.1016/j.ijnurstu.2012.11.018. Epub 2012 Dec 14.
    Results Reference
    result
    PubMed Identifier
    24035670
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    24079640
    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.
    Results Reference
    result

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

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