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Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

Comparison of Valsalva Maneuver and Control in Reducing Pain During Spinal Injection

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04215276
Enrollment
70
Registered
2020-01-02
Start date
2019-01-21
Completion date
2019-04-26
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachytherapy

Keywords

valsalva maneuver, control, pain, spinal injection

Brief summary

The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological approach and control in reducing pain during spinal injection.

Detailed description

This was an experimental study on 70 subjects with 35 subjects treated with Valsalva maneuver and 35 subjects treated as control from January to April 2019. Research subjects were female who underwent brachytherapy for the first time with spinal anesthesia. The effectiveness in reducing pain was assessed by using Visual Analogue Scale (VAS) and patient movement during the surgery.

Interventions

pressure during Valsalva maneuver was measure using sphygmomanometer

OTHERControl

patient was not given any intervention

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* patients underwent elective surgery using spinal anesthesia * patients who have not undergone spinal anesthesia before * Physical status ASA I or II * Signing informed consent

Exclusion criteria

* have a spinal anesthesia history * contraindicated for spinal anesthesia * subjects who cannot do Valsalva to 30mmHg pressure for 20 seconds * have a allergic history to local anesthetics or opioid drugs

Design outcomes

Primary

MeasureTime frameDescription
Pain measurement during injection with VAS score30 secondsPain degree was measured with VAS score \[0 equals to no pain whereas 10 equals to the maximum pain\]

Secondary

MeasureTime frameDescription
Patient movement30 secondsInvestigator observes patient movement during the first spinal injection

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026