The goal of this clinical trial is to learn if transcutaneous electrical nerve stimulation (TENS) can reduce perioperative pain in older adults with hip fractures. It will also evaluate its effects on physiological and psychological outcomes. The main questions it aims to answer are: Does adding TENS to usual care during the preoperative phase reduce pain intensity and analgesic consumption? Does TENS affect pressure pain threshold and vital signs (blood pressure, heart rate, and respiratory rate)? Researchers will compare active TENS to sham TENS (no perceptible stimulation) to see if TENS is effective in reducing pain and improving related outcomes. Participants will: * Undergo a standardized baseline assessment, including evaluation of pain, vital signs, anxiety, discomfort, and pressure pain threshold * Complete questionnaires assessing quality of life, physical activity, depressive symptoms, anxiety, fear of falling, and pain catastrophizing * Be randomly assigned to receive either active TENS or sham TENS * Receive a single 45-minute TENS session * Have their analgesic use recorded for the 24 hours before and after the intervention.
Hip fractures in older adults are commonly associated with significant perioperative pain, which is often managed with opioid analgesics despite their potential adverse effects. Non-pharmacological and non-invasive strategies, such as transcutaneous electrical nerve stimulation (TENS), have been proposed as adjunctive approaches for pain management. While previous studies have primarily focused on postoperative applications, the effects of TENS during the preoperative phase remain unclear. This randomized clinical trial will include 32 older adults diagnosed with hip fracture. After providing written informed consent, participants will undergo a standardized baseline assessment. Demographic and clinical data, including age, sex, marital status, and education level, will be collected through an anamnesis form. Physiological and clinical outcomes will be assessed before and after the intervention. These include vital signs (blood pressure, heart rate, and respiratory rate), pain intensity, discomfort level, anxiety level, and pressure pain threshold. Additionally, validated instruments will be applied once prior to the intervention to assess broader health domains, including quality of life (SF-36), physical activity level (International Physical Activity Questionnaire - IPAQ), depressive symptoms (Geriatric Depression Scale), anxiety symptoms (State-Trait Anxiety Inventory), fear of falling (Falls Efficacy Scale International), and pain catastrophizing (Pain Catastrophizing Scale). Following baseline assessments, participants will be randomly assigned to one of two groups. The intervention group (G1) will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant. The control group (G2) will receive sham TENS, with intensity set at a sub-sensory level without perceptible stimulation. The intervention will consist of a single session lasting 45 minutes. Analgesic consumption will be evaluated based on the type and quantity of medications used by participants in the 24 hours before and 24 hours after the intervention. These data will be obtained from medical records and prescription information. This study aims to provide evidence regarding the effectiveness of preoperative TENS as an adjunct to usual care for pain management and its potential influence on physiological and psychological outcomes in older adults with hip fractures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Active transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity adjusted to the maximum level tolerated by the participant.
Sham transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity set at a sub-sensory level, with no perceptible stimulation.
Pain intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. Higher scores represent worse outcomes.
Time frame: Before and immediately after the intervention (single session)
Pressure pain threshold
Pressure pain threshold will be measured using a pressure algometer.
Time frame: Before and immediately after the intervention
Blood pressure
Blood pressure will be measured before and after the intervention.
Time frame: Before and immediately after the intervention
Analgesic consumption
Analgesic use will be assessed based on the type and quantity of medications recorded in medical records.
Time frame: 24 hours before and 24 hours after the intervention
Quality of life (SF-36)
Quality of life will be assessed using the Short Form Health Survey (SF-36), ranging from 0 to 100, where higher scores indicate better quality of life.
Time frame: Baseline (pre-intervention)
Physical activity level (IPAQ)
Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ), expressed in MET-minutes/week. Higher values indicate higher levels of physical activity.
Time frame: Baseline
Depressive symptoms
Depressive symptoms will be assessed using the Geriatric Depression Scale (GDS), ranging from 0 to 15, where higher scores indicate more severe depressive symptoms.
Time frame: Baseline
Anxiety symptoms
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), ranging from 20 to 80, where higher scores indicate greater anxiety levels.
Time frame: Baseline
Fear of falling
Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I), ranging from 16 to 64, where higher scores indicate greater concern about falling.
Time frame: Baseline
Pain catastrophizing
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), ranging from 0 to 52, where higher scores indicate greater levels of catastrophizing.
Time frame: Baseline
Heart rate
Heart rate will be measured before and after the intervention.
Time frame: Before and immediately after the intervention
Respiratory rate
Respiratory rate will be measured before and after the intervention.
Time frame: Before and immediately after the intervention
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