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

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

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

Study Overview

• Status: Completed
• Conditions: Cannulation,Pain
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Turkey
  • Tokat, Turkey, 60200
    • Gaziosmanpasa University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients that underwent surgery

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale	Pain intensity	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction scale	satisfaction level(worst,bad,none,good,better)	one month

Collaborators and Investigators

• Sponsor: Tokat Gaziosmanpasa University
• Investigators: Principal Investigator: Hakan Tapar, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): July 9, 2017

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 17-KAEK-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No