Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy

RecruitingOBSERVATIONAL
Enrollment

436

Participants

Timeline

Start Date

July 23, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
HysterectomyChronic PainCentral SensitisationAnxiety Depression
Interventions
DIAGNOSTIC_TEST

Pain-Pressure Threshold

Performed on bilateral trapezius muscles. Pressure will be applied at 90 degrees downward with an algometer, with the speed of pressure increase approximately 1kgf/s. Upon the sensation of pain, the patient will vocalize or raise her hand to terminate the test, and the highest reading will be recorded (up to maximum 6kgf). If two values are recorded within 0.2kgf of each other, the mean value will be recorded. If two values are greater than 0.2kgf of each other, a third test will be performed and the mean obtained.

DIAGNOSTIC_TEST

Mechanical Temporal Summation

"Pinprick hyperalgesia will be evoked using a Von Frey filament, applied to the volar aspect of the dominant forearm. Participants will report using the numerical rating scale the intensity of pain from the first stimulus. Subsequently, ten repetitive stimuli one second apart will be applied with the same filament within an area of 1cm diameter of the same forearm. Subjects will report the rate the pain intensity of the tenth stimulus. The magnitude of MTS is calculated as the difference between the last to the first pain scores. The investigators will classify the participants according to evoked MTS if the last stimulus is rated higher than the first, or no MTS if the last stimulus is rated equal or lower than the first. The research team administering the test will follow a set script."

DIAGNOSTIC_TEST

Hospital Anxiety and Depression Scale

Standardized questionnaire to determine the level of anxiety and depression.

DIAGNOSTIC_TEST

Pain Catastrophizing Scale

Standardized questionnaire to determine the level of pain catastrophizing.

DIAGNOSTIC_TEST

Central Sensitization Inventory

Standardized questionnaire to determine the level of central sensitization.

DIAGNOSTIC_TEST

Fear-Avoidance Component Score

Standardized questionnaire to determine the level of fear and avoidance.

DIAGNOSTIC_TEST

EQ-5D

Standardized questionnaire to assess generic health-related quality of life.

DIAGNOSTIC_TEST

heart rate variability

Heart rate variability will be determined from the R-to-R intervals obtained from a 5-minute ECG recording.

DIAGNOSTIC_TEST

Anxiety, anticipated pain, anticipated analgesia

Preoperative anxiety (0 to 100), anticipated pain (0 to 100), and anticipated analgesia requirement (0 to 5).

DIAGNOSTIC_TEST

State-trait anxiety inventory

Standardized questionnaire to assess anxiety.

DIAGNOSTIC_TEST

Beck's Depression Inventory

Standardized questionnaire to assess depressive symptoms.

Trial Locations (1)

229899

RECRUITING

KK Women's and Children's Hospital, Singapore

All Listed Sponsors
lead

KK Women's and Children's Hospital

OTHER_GOV