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

NCT ID: NCT01987440

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-05-31

Brief Summary

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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 The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained.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.

Group Type: EXPERIMENTAL

lubricating gel

Intervention Type: DRUG

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 The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained.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.

Group Type: PLACEBO_COMPARATOR

lubricating gel

Intervention Type: DRUG

Interventions

lubricating gel

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tepecik Education and REserch Hospital

Izmir, Tepecik, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

gungorduk16

Identifier Type: -

Identifier Source: org_study_id