Pain During Outpatient Hysteroscopy, Pain Reduction in Outpatient Hysteroscopy
Conditions
Keywords
Outpatient hysteroscopy
Brief summary
The goal of this randomized clinical trial is to determine whether using warmed saline at 37°C during outpatient diagnostic hysteroscopy can reduce pain compared with room-temperature saline. The study will include women aged 18 to 70 years who are undergoing outpatient diagnostic hysteroscopy. Participants will be randomly assigned to receive either warmed saline at 37°C or room-temperature saline as the fluid used to expand the uterine cavity during the procedure. Data collected will then be used to compare pain scores between the two groups during hysteroscopy and one hour after the procedure. The study will also assess whether participants require additional pain medication and whether the procedure is stopped because of severe pain. The main hypothesis is that warmed saline at 37°C will result in lower pain scores than room-temperature saline.
Detailed description
Outpatient diagnostic hysteroscopy is commonly performed for the evaluation of intrauterine abnormalities and other gynecological indications. Pain during hysteroscopy may be influenced by cervical manipulation, uterine distension, and uterine contractions. The temperature of the distension medium may influence patient discomfort during the procedure. This study is a parallel-group superiority randomized controlled trial designed to compare warmed normal saline at 37°C with room-temperature normal saline as the uterine distension medium during outpatient diagnostic hysteroscopy. Eligible participants will be women aged 18 to 70 years who are scheduled for outpatient diagnostic hysteroscopy and who are able to understand and report pain using a visual analog scale. Participants will provide written informed consent before enrollment. A total of 60 participants will be randomized in a 1:1 ratio to one of two study groups. The intervention group will undergo hysteroscopy using normal saline warmed to 37°C. The comparison group will undergo hysteroscopy using normal saline at room temperature. The temperature of the saline will be monitored using an infrared thermometer. Pain intensity during the hysteroscopy will be assessed using a 0-to-10 visual analog scale and will constitute the primary outcome of the study. Secondary outcomes will include pain intensity one hour after the procedure, the need for additional analgesia during or after the procedure, and the proportion of participants in whom the procedure is abandoned because of intolerable pain. The study will be conducted in the outpatient Endoscopy Unit of Demerdash Maternity Hospital, Ain Shams University. Diagnostic hysteroscopy will be performed using a 5-mm Karl Storz hysteroscope by the same senior physician. The study is designed to determine whether the use of warmed saline at 37°C provides a clinically meaningful reduction in pain compared with room-temperature saline during outpatient diagnostic hysteroscopy.
Interventions
OTHERWarmed Saline at 37 degrees celsius
Normal saline warmed to 37°C and used as the uterine distension medium during outpatient diagnostic hysteroscopy. The temperature of the saline will be monitored using an infrared thermometer before and during the procedure.
OTHERRoom-Temperature Normal Saline
Normal saline at room temperature used as the uterine distension medium during outpatient diagnostic hysteroscopy.
Sponsors
Reem Mohamed
Ain Shams Maternity Hospital
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-70 years. * Ability to understand and report pain using the Visual Analog Scale. * Willingness to undergo outpatient hysteroscopy and provide written informed consent.
Exclusion criteria
* Congenital genital tract malformations: including these patients could introduce a confounding factor because pain may result from difficult anatomy rather than the temperature of the distension medium. * Previous hysteroscopic procedures: pain perception may be influenced by prior experience rather than the intervention itself * Suspected pregnancy: standard gynecologic practice considers pregnancy a contraindication to elective diagnostic hysteroscopy * Active pelvic infection: instrumentation of an infected genital tract may increase morbidity and facilitate ascending infection. Also, pain scores may reflect infection-related pain rather than procedural pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during outpatient diagnostic hysteroscopy measured using the Visual Analog Scale (VAS) | During the hysteroscopy procedure | Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. The VAS score recorded immediately after the hysteroscopy will be compared between participants receiving warmed normal saline at 37°C and those receiving room-temperature normal saline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for additional analgesia after outpatient diagnostic hysteroscopy | 1 hour after completion of the procedure | The need for additional analgesia will be recorded as a binary outcome according to whether the participant requires analgesic medication. The proportion of participants requiring additional analgesia will be compared between the warmed saline at 37°C group and the room-temperature saline group. |
| Proportion of procedures abandoned due to intolerable pain | During the hysteroscopy procedure | The proportion of participants in whom outpatient diagnostic hysteroscopy is abandoned because of intolerable pain will be recorded and compared between the warmed saline at 37°C group and the room-temperature saline group. |
| Pain intensity one hour after outpatient diagnostic hysteroscopy measured using the Visual Analog Scale (VAS) | 1 hour after completion of the hysteroscopy | Pain intensity will be assessed one hour after completion of the hysteroscopy using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. VAS pain scores will be compared between participants receiving warmed normal saline at 37°C and those receiving room-temperature normal saline. |
Countries
Egypt
Contacts
CONTACTReem M Sadiq, MBBCh
Outcome results
None listed