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Completed

NCT Number: NCT03213782

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nature based sounds

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Maharishi Markendeswar University (Deemed to be University)

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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