NCT03125317

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 19, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2017

Completed
Last Updated

July 19, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

April 19, 2017

Last Update Submit

July 17, 2017

Conditions

Cannulation,Pain

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    Pain intensity

    one month

Secondary Outcomes (1)

  • satisfaction scale

    one month

Study Arms (3)

The music group

Participant will allow to listen any kind of music which they wish

Other: Music

valsalva maneuver

participants will be asked to take a deep breath and exhale the air out in 15 seconds

Other: Valsalva maneuver

The control group

no intervention

Other: control

Interventions

MusicOTHER

a kind of music which the participant likes will be listened using speakers

The music group
Valsalva maneuverOTHER

Participant will be asked to take a deep breath and exhale the air out in 15 seconds

valsalva maneuver
controlOTHER

No intervention

The control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that underwent surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Music TherapyValsalva Maneuver

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaRespiratory Physiological Phenomena

Study Officials

  • Hakan Tapar

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 24, 2017

Study Start

April 20, 2017

Primary Completion

June 30, 2017

Study Completion

July 9, 2017

Last Updated

July 19, 2017

Record last verified: 2017-04

Locations

TU(1)