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Effect of Hand-Holding on Anxiety and Pain During Transrectal Prostate Biopsies: a Pilot Randomized Controlled Trial

Effect of Hand-Holding on Anxiety and Pain During Transrectal Prostate Biopsies: a Pilot Randomized Controlled Trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032238
Enrollment
Unknown
Registered
2020-04-23
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

prostate biopsy

Interventions

HR group:hand-holding with relatives
HS group:hand-holding with strangers
control group:N/A

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Participants who met one of the following inclusion criteria were eligible for the study: (1) PSA (Prostate-specific antigen) > 10.0 ng / mL; (2) PSA> 4.0 ng / mL and free/total PSA ratio 0.75ng / mL / year; (4) An abnormal digital rectal examination (DRE) or imaging (TRUS, MRI) found suspicious areas.

Exclusion criteria

Exclusion criteria: Exclusion criteria consisted of several parameters: (1) diseases prone to severe bleeding; (2) during acute infection and fever; (3) hypertensive crisis; (4) in the decompensation period of cardiac dysfunction; (5) in the unstable blood glucose stage of diabetes; (6) have used analgesics or sedative drugs within 24 hours before TRUS-PBx; (7) allergic to oxybuprocaine; (8) significant communication difficulties, severe hearing loss, or inability to complete the required surveys.

Design outcomes

Primary

MeasureTime frame
pain intensity;Anxiety levels;

Secondary

MeasureTime frame
satisfaction level;hemodynamic change;

Countries

China

Contacts

Public ContactPan Weixin

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

kuangfeng0612@126.com+86 13818072143

Outcome results

None listed

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