Cannulation,PainNCT03125317
Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation
An observational study of Cannulation,Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous cannulation pain and anxiety Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cannulation,Pain
- What is being tested?
- Music and Valsalva maneuver
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2017to 9 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that underwent surgery
Who may be able to join
- American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery
Who cannot join
- Patients with a history of anxiety disorders or hearing problem and preoperative pain.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
Official title: 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
Read the 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.
- Conditions
- Cannulation,Pain
- Being tested
- Music, Valsalva maneuver, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
a kind of music which the participant likes will be listened using speakers
Valsalva maneuverOther
Participant will be asked to take a deep breath and exhale the air out in 15 seconds
controlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| The music group | Participant will allow to listen any kind of music which they wish Receives: Other: Music | |
| valsalva maneuver | participants will be asked to take a deep breath and exhale the air out in 15 seconds Receives: Other: Valsalva maneuver | |
| The control group | no intervention Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Pain intensity
Measured: one month
Secondary outcomes (1)
satisfaction scale
satisfaction level(worst,bad,none,good,better)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start20 Apr 2017
- Primary completion30 Jun 2017
- Study completion9 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannulation,PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125317
- Sponsor's protocol ID
- 17-KAEK-009
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Valsalva's Maneuver and Music Therapy on Peripheral Venous Cannulation Pain and Anxiety
- ClinicalTrials.gov ID
- NCT03125317
- Acronym / sponsor ID
- 17-KAEK-009
- Conditions
- Cannulation,Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 9 Jul 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the efficacy of Valsalva's maneuver and music therapy on peripheral venous cannulation pain and anxiety
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The music group | – | Other: MusicParticipant will allow to listen any kind of music which they wish |
| valsalva maneuver | – | Other: Valsalva maneuverparticipants will be asked to take a deep breath and exhale the air out in 15 seconds |
| The control group | – | Other: controlno intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that underwent surgery
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery
Key exclusion criteria (1 listed)
- Patients with a history of anxiety disorders or hearing problem and preoperative pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musica kind of music which the participant likes will be listened using speakers | Other | The music group |
| Valsalva maneuverParticipant will be asked to take a deep breath and exhale the air out in 15 seconds | Other | valsalva maneuver |
| controlNo intervention | Other | The control group |
Primary outcome
Visual analog scale
Time frame: one month
Pain intensity
1 secondary outcome
satisfaction scale
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Cannulation,Pain
Not yet recruiting
Is Pain Ease (New Formula) Safe and Effective in Reducing Pain Associated With Peripheral Intravenous Cannulation (PIV)?
Peripheral Intravenous Cannulation, Pain Management
Active, not recruiting
Cryotherapy for Reducing Fistula Puncture Pain in Hemodialysis Patients
Pain, Procedural (During Sternum Dressing on Infants), Arteriovenous Fistula
Not yet recruiting
Effect of 4-7-8 Breathing on AV Fistula Needle Pain in Dialysis Patients
Chronic Kidney Diseases, Pain, Procedural
Not yet recruitingObservational study
Prediction of Postoperative Pain Using Venous Cannulation Pain and Preoperative Anxiety Scores
Preoperative Anxiety, Postoperative Pain
Not yet recruiting
Cold-Induced Vagal Stimulation for Attenuating Venipuncture Pain in Obese Individuals
Venipuncture Pain, Vagal Nerve Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Tapar principal investigator
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannulation,Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.