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The effectiveness of vibratory stimulation in reducing pain severity from spinal needle puncture in patients undergoing hernia surgery under spinal anesthesia: A Randomized, Single-Blinded, Controlled Clinical Trial

The effectiveness of vibratory stimulation in reducing pain severity from spinal needle puncture in patients undergoing hernia surgery under spinal anesthesia: A Randomized, Single-Blinded, Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241218001
Enrollment
76
Registered
2024-12-18
Start date
2024-12-23
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pain Spinal anesthesia Hernia surgery Spinal anesthesia Vibratory stimulation Buzzy device Hernia surgery Visual Analog Scale Pain severity Randomized controlled trial

Interventions

In the intervention group, the BUZZY Healthcare Kit device (MMJ Labs LLC, Atlanta, GA, USA) without blue gel ice wings will be activated to provide vibratory stimulation. The device will be placed 2 c
Experimental Device,Placebo Comparator Device
buzzy,control

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1 Patients undergoing elective hernia surgery with spinal anesthesia 2 Aged 18-65 years 3 ASA physical status classification 1-3

Exclusion criteria

Exclusion criteria: 1 Refusal of spinal anesthesia 2 Contraindications to spinal anesthesia 3 Pregnant or breastfeeding women 4 Inability to undergo surgery with spinal anesthesia alone 5 Patients unable to communicate or with neurological impairment 6 Use of analgesics within 24 hours prior to surgery 7 Patients requiring more than one attempt at spinal anesthesia

Design outcomes

Primary

MeasureTime frame
visual analog scale After completion of the anesthesia injection score

Secondary

MeasureTime frame
Systolic blood pressure the peak heart rate within the first 10 seconds after needle withdrawal mmHg,Diastolic blood pressure the peak heart rate within the first 10 seconds after needle withdrawal mmHg

Countries

Thailand

Contacts

Public ContactWipawan Panomchai

Debaratana Nakhon Ratchasima Hospital

kate29.max@gmail.com0638247465

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026