Electronic continuous pain measurement versus Verbal Rating Scale in gynaecology

• Register: ISRCTN
• Last refreshed on: 20 February 2017
• Main ID: ISRCTN15427669
• Date of registration: 30/01/2017
• Prospective Registration: No
• Primary sponsor: VU University Medical Center
• Public title: Electronic continuous pain measurement versus Verbal Rating Scale in gynaecology
• Scientific title: Electronic continuous pain measurement versus Verbal Rating Scale in gynaecology: a prospective observational cohort study
• Date of first enrolment: 01/08/2011
• Target sample size: 108
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15427669
• Study type: Observational
• Study design: Prospective multi-centre observational cohort study (Diagnostic)

Countries of recruitment

Netherlands

Contacts

• Name: Marjoleine Louwerse

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged between 18-80 years
2. Scheduled for a hysteroscopy, colposcopy or ovum pick-up in an outpatient setting
Exclusion criteria: 1. Inability to comprehend Dutch or English properly
2. For hysteroscopy: pregnancy or women in the luteal phase without the use of contraception, known cervical stenosis or malignancy, current Sexual Transmitted Disease (STD) or Pelvic Inflammatory Disease (PID) or contra-indications for the use of NSAIDs

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Gynaecological procedures
Urological and Genital Diseases
Gynaecological procedures

Intervention(s)

Before the procedure, patients have their anxiety score recorded. When the patient is positioned, she receives instructions on the use of the CPSM and as a part of this instruction the meter is tested once before the start of the procedure by giving the patient a mild pressure stimulus on her hand. Then, women are asked to express their pain by controlling the CPSM during the entire procedure. Immediately after the procedure, participants are asked to express the experienced average pain during the entire procedure, using the Verbal Rating Scale (VRS). Tolerability of the procedure is also reported at this point.

After a period of two years women are telephoned and asked to report the VRS and tolerability of the procedure again to determine what the effect is of recollection on pain perception.

Primary Outcome(s)

Pain of outpatient gynecological procedure is measured using the Verbal Rating Scale (VRS 0-10) directly after a procedure versus pain measurement and using the Continuous Pain Score Meter (CPSM, CPSM-AUC, CPSM-PPS, CPSM-APS) during the procedure.

Secondary Outcome(s)

1. Recollection of pain perception is assessed using the Verbal Rating Scale (VRS 0-10) after two years
2. Anxiety is measured using a numerical rating scale (0-10) at baseline
3. Tolerability of the procedure is assessed post-surgery and after two years

Secondary ID(s)

N/A

Source(s) of Monetary Support

VU University Medical Center