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

NCT01987440 | Completed

• 1 other identifier: gungorduk16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  During Speculum Examination Dilatation stage

  During Speculum Examination Dilatation stage

Secondary Outcomes (1)

• visual analog scale insertion stage

  uring Speculum Examination insertion stage

Other Outcomes (1)

• VAS score extraction

  Durig extraction the speculum

Study Arms (2)

Lubricating Gel

EXPERIMENTAL

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 The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained.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

water

PLACEBO COMPARATOR

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 The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained.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

Interventions

lubricating gel DRUG

Lubricating Gel; water

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \*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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Tepecik Education and REserch Hospital

Izmir, Tepecik, 35600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 13, 2014

Record last verified: 2014-06

Locations

TU (1)