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Clinical Trials/CTRI/2024/04/066140
CTRI/2024/04/066140CompletedNot Applicable

Effectiveness of transcutaneous electrical nerve stimulation in addition to routine physiotherapy care on quality of life and pain after abdominal hysterectomy: A Randomized Controlled Trial.

Priyadharshini R1 site in 1 country32 target enrollmentStarted: May 23, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
32
Locations
1
Primary Endpoint
Abdominal surgery impact scale

Study Overview

Brief Summary

Effectiveness of Transcutaneous Electrical Nerve Stimulation in addition to Routine Physiotherapy care on Quality of Life and Pain after Abdominal hysterectomy: A Randomized Controlled Trial.

After the Abdominal hysterectomy the incisional pain is more ,it causes the negative impact of the patient physical and mental health. Post operative pain reduce the Quality of Life. The preferred post operative pain is opioid usage. However due to opioid- related side effects, including emesis and itiching , opioid use can lead to poor Quality of Life ,Thus, contemporary pain therapy aims to reduce opioid usage via multimodal technique. includes Breathing exercises, Coughing techniques, Circulatory exercises, Knee rolling, log rolling, patient made to sit, Abdominal exercises, Pelvic tilting, Getting in and out of the bed, Pelvic floor exercises and mobilization around the ward, outside the ward and stair climbing, All the exercises were performed. Transcutaneous Electrical Nerve Stimulation is non invasive, non pharmacological and low frequency electrotherapy technique has been used for pain after Abdominal hysterectomy. There is a lack of awareness about Transcutaneous Electrical Nerve Stimulation (TENS) usage in addition to Routine physiotherapy care. There is a urgent need for research on the Effectiveness of Transcutaneous Electrical Nerve Stimulation in addition Routine Physiotherapy care improve Quality of Life and reduce Pain after Abdominal hysterectomy. Outcome measure used for Abdominal Surgery Impact Scale (ASIS), and Visual Analogue Scale (VAS)

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
35.00 Year(s) to 55.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Women undergoing Abdominal hysterectomy in OG I unit OT days (Wednesday & Saturday) in their postoperative days 1 to
  • Willing to participate in the study.
  • Pain score ≥3 measured by the Visual analogue scale (VAS) / pain of 5 or greater on a 0 to 10 numerical rating scale (NRS) or moderate on a verbal descriptive scale were approached to participate in the study.

Exclusion Criteria

  • Preoperative opioid use (regular use of opioid analgesics for more than 2 weeks during the 6 month period before surgery as determined by patient interview).
  • Inability to cognitively follow the required directions.
  • Participator’s inability to fully complete with study protocol due to uncontrolled epilepsy, Renal failure, Cardiopulmonary disorders, Central nervous system disease (or) psychosis.
  • Coagulation disorders.
  • Any sign of sepsis.
  • Any specialties surgery of the head (brain, face), neck ( Thyroid, throat) Thoracic (cardio , pulmonary) , breast, Orthopaedic including amputations (or) reset of amputation (phantom limb pain) , (or) Plastic surgery (Liposuction) were not considered.
  • Any skin allergy(dermatological lesions affecting electrode placement).

Outcomes

Primary Outcomes

Abdominal surgery impact scale

Time Frame: Outcome taken from post operative day 1 and post operative day 6

Secondary Outcomes

  • Visual analogue scale(Post operative day 1 before & after intervention)

Investigators

Sponsor
Priyadharshini R
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

PRIYADHARSHINI R

Mother Theresa Post Graduate and Research Institute of Health science (Government of Pondicherry)

Study Sites (1)

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