NCT05246436

Brief Summary

The aim of study is to determine if the use of warm saline distention media during outpatient hysteroscopy reduces Pain/discomfort of the procedure. Research hypothesis: In women undergoing office hysteroscopy, there will be reduced pain perception when using warm saline (body temperature 37°C during office hysteroscopy. Research question: In women undergoing office hysteroscopy, Will there be a difference in pain perceived during the procedure if the investigators use warm saline(body temperature 37°C) rather than normal saline (room temperature) as a distension media?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

January 12, 2022

Last Update Submit

February 17, 2022

Conditions

Office Hysteroscopy

Keywords

warm saline

Outcome Measures

Primary Outcomes (1)

  • warm saline versus room temp. saline as a distention media in office hysteroscopy in reliving pain by usage of the visual analog scale (VAS)

    The patient makes a mark on the visual analog scale line to indicate the intensity of her pain. Pain will be measured using a 10-cm visual analogue scale (VAS) graded from 0 to 10 , (0) means no pain (better outcome), and (10) means worst possible pain (worse outcome)

    base line

Secondary Outcomes (1)

  • The clarity of the view.(questionnaire).

    base line

Other Outcomes (4)

  • The ease of entry of the hysteroscopy.(questionnaire)

    base line

  • Patient satisfaction.(questionnaire)

    base line

  • Time of the procedure.(time by minutes)

    base line

  • +1 more other outcomes

Study Arms (2)

warm saline

ACTIVE COMPARATOR

Patients who used warm saline as a distention media in office hysteroscopy

Procedure: warming saline media

room temperature saline

SHAM COMPARATOR

Patients who used room temprature saline as a distention media in office hysteroscopy

Procedure: room temperature saline media

Interventions

warming saline mediaPROCEDURE

use warm saline as a distention media in office hysteroscopy

warm saline
room temperature saline mediaPROCEDURE

use room temperature saline as a distention media in office hysteroscopy

room temperature saline

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Age ≥ 18 years old.
  • Indications of diagnostic hysteroscopy: Cases complaining of abnormal uterine bleeding and /or undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal Ostia for infertility, removal of foreign body, Suspected Mullerian anomalies.

You may not qualify if:

  • \- Contra-indications of diagnostic hysteroscopy: unable to exclude pregnancy, acute pelvic infection, active genital herpes, confirmed cervical or endometrial cancer and profuse bleeding at the time of the procedure.
  • Any usage of analgesic agent on the day of the procedure.
  • Failure of entry of the cervical canal requiring cervical dilatation.
  • Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.
  • Patient refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363.

    PMID: 29949273BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 18, 2022

Study Start

April 1, 2021

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

EG(1)