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

Erzincan Military Hospital

Status: Completed

Conditions: Pain

Treatments: Drug: lubricating gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01987440

gungorduk16

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Lubricating Gel

Experimental group

Description:

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 The speculum was withdrawn slightly, which allowed the bill to close together, and at this stage (extraction) the final VAS score was obtained.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

Treatment:

Drug: lubricating gel

water

Placebo Comparator group

Description:

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.

Treatment:

Drug: lubricating gel