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Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation

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ClinicalTrials.gov Identifier: NCT03125317
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hakan Tapar, Tokat Gaziosmanpasa University

Brief Summary:
Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous cannulation pain and anxiety

Condition or disease Intervention/treatment
Cannulation,Pain Other: Music Other: Valsalva maneuver Other: control

Detailed Description:
One hundred and fifty patients undergoing surgery were randomized to apply Valsalva's maneuver (the valsalva group) and music therapy(the music group) and a placebo (the control group) during peripheral venous cannulation (PVC). The patients' pain, anxiety, and satisfaction scores will be measured.

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Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation Pain and Anxiety
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : July 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
The music group
Participant will allow to listen any kind of music which they wish
Other: Music
a kind of music which the participant likes will be listened using speakers

valsalva maneuver
participants will be asked to take a deep breath and exhale the air out in 15 seconds
Other: Valsalva maneuver
Participant will be asked to take a deep breath and exhale the air out in 15 seconds

The control group
no intervention
Other: control
No intervention




Primary Outcome Measures :
  1. Visual analog scale [ Time Frame: one month ]
    Pain intensity


Secondary Outcome Measures :
  1. satisfaction scale [ Time Frame: one month ]
    satisfaction level(worst,bad,none,good,better)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients that underwent surgery
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery

Exclusion Criteria:

  • Patients with a history of anxiety disorders or hearing problem and preoperative pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125317


Locations
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Turkey
Gaziosmanpasa University
Tokat, Turkey, 60200
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: Hakan Tapar Assistant professor

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Responsible Party: Hakan Tapar, Assistant Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT03125317     History of Changes
Other Study ID Numbers: 17-KAEK-009
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No