A clinical trial to test whether music and noise cancellation headphones during pacemaker implantation procedure reduces perception of pain and anxiety.

Does perioperative Music and noise cancellation headphones reduce perception of Pain and Anxiety in patients undergoing paCEmaker implantation: Randomised control trial (M-PACE trial) - M-PACE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063898

Enrollment

270

Registered

2024-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: I442- Atrioventricular block, complete Health Condition 2: I441- Atrioventricular block, second degree Health Condition 3: I453- Trifascicular block

Interventions

Intervention1: Music therapy via noise cancellation headphones: Patients undergoing pacemaker implantation under local anaesthesia will be administered music through a noise cancellation headphone dur

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing dual chamber pacemaker implantation under local anaesthesia

Exclusion criteria

Exclusion criteria: Hearing impairment, High baseline anxiety score and patient with known Psychiatric disorders like generalized anxiety disorders, depression, and bipolar disorders

Design outcomes

Primary

Measure	Time frame
To compare the postoperative STAI-6 anxiety score between the study groupsTimepoint: Baseline (preprocedure and 3 hours postprocedure)	—

Secondary

Measure	Time frame
1. To compare the postoperative pain score as measured by VAS between the study groups. 2. To compare the change in STAI-6 anxiety score (postprocedure and preprocedure) between the study groups. 3. To compare the change in pain score (postprocedure and preprocedure) as measured by VAS between the study groupsTimepoint: Baseline (preprocedure and 3 hours postprocedure)	—

Countries

India

Contacts

Public ContactAnand Manickavasagam

Christian Medical College

dranandchn@gmail.com04172224715

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026