Effect of Lubricating Gel for Pain Relief During Speculum Examination in Gynecologic Oncology Patients

Pelvic examination, an important part of gynecologic oncology patients to help detect cancers recurrence or infections.Despite its importance, many women are reluctant and anxious about the procedure because of fear, as well as discomfort and pain. The objective of this study is to estimate whether using lubricating gel decreases patient pain during speculum insertion compared with using water in gynecologic oncology patients

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: lubricating gel

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Tepecik
    • İzmir, Tepecik, Turkey, 35600
      • Tepecik Education and REserch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

*Female patients WHO came for surveillance for malignant gynecologic disease such as uterine cancer, cervix cancer, and ovarian cancer with or without radiotherapy and chemotherapy

Exclusion Criteria

• Women were undergoing Vulvectomy or Vaginectomy
• Women with narrow vagina for standard medium size of speculum for examination
• Women who underwent fertility sparing surgery.
• Women had vaginitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lubricating Gel; The speculum was warmed, and patients were informed about what was going to happen. The labia were spread from below to introduce the speculum, which was inserted at a 45-degree angle pointing downward then rotated horizontally as the insertion continued. A VAS score (insertion) was obtained at this point. Next, the bill of the speculum was opened up until the vaginal cuff could be seen, and the speculum was secured by turning the thumbnut. A second VAS score (dilation) was recorded. During speculum examination, cervical smear with cervical brush was obtained for pathologic assessment if necessary. The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained. In the gel group , a doctor placed 6,5 mL mL sterile lubricating gel on the top and bottom blades of the speculum. Length of the vagina was measured by the index finger.	Drug: lubricating gel
Placebo Comparator: water; A VAS score (insertion) was obtained at this point. Next, the bill of the speculum was opened up until the vaginal cuff could be seen, and the speculum was secured by turning the thumbnut. A second VAS score (dilation) was recorded. During speculum examination, cervical smear with cervical brush was obtained for pathologic assessment if necessary. The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained. In the water group the speculum's top and bottom blades were moistened with 6,5 mL tap water previously loaded into a syringe kept at room temperature.After the speculum examination, pelvic examination was performed and length of the vagina (defined as distance from vaginal cuff to vaginal apex) was measured by the index finger.	Drug: lubricating gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	During Speculum Examination Dilatation stage	During Speculum Examination Dilatation stage

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale insertion stage	During Speculum Examination insertion stage	uring Speculum Examination insertion stage

Other Outcome Measures

Outcome Measure	Time Frame
VAS score extraction	Durig extraction the speculum

Collaborators and Investigators

• Sponsor: Erzincan Military Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 12, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 19, 2013

Study Record Updates

• Last Update Posted (Estimate): June 13, 2014
• Last Update Submitted That Met QC Criteria: June 12, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: gungorduk16