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

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987440
• Other study ID #: gungorduk16
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: June 12, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Erzincan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTurkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lubricating gel

Locations

Country	Name	City	State
Turkey	Tepecik Education and REserch Hospital	Izmir	Tepecik

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS score extraction		Durig extraction the speculum	Yes
Primary	Visual Analog Scale	During Speculum Examination Dilatation stage	During Speculum Examination Dilatation stage	Yes
Secondary	visual analog scale insertion stage	During Speculum Examination insertion stage	uring Speculum Examination insertion stage	Yes