ClinicalTrials.gg
CompletedNCT07921524TENS-HYSTUpdated Nov 6, 2026

Effects of TENS on Mobility, Anxiety, and Recovery After Hysterectomy

An interventional study of Transcutaneous Electrical Nerve Stimulation (TENS) in Hysterectomy, sponsored by Inonu University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2026, registered Nov 2026).
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

This randomized controlled trial evaluated the effects of transcutaneous electrical nerve stimulation (TENS) on mobility, anxiety, and quality of recovery in women undergoing hysterectomy.

Participants were assigned to either an intervention group receiving TENS in addition to routine postoperative care or a control group receiving routine postoperative care alone. In the intervention group, TENS was administered in two 20-minute sessions during the early postoperative period.

Patient mobility, observer-rated mobility, anxiety, and quality of recovery were assessed using standardized measurement instruments.

The study aimed to determine whether adding TENS to routine postoperative care could improve early postoperative mobility, reduce anxiety, and enhance recovery quality following hysterectomy.

Read the detailed description

Hysterectomy is a common gynecological surgical procedure. During the early postoperative period, patients may experience difficulties with mobilization, anxiety, and reduced quality of recovery. Non-pharmacological interventions that support postoperative recovery are therefore clinically relevant.

This study was designed as a randomized controlled trial to investigate the effects of transcutaneous electrical nerve stimulation (TENS) on postoperative mobility, anxiety, and quality of recovery in women undergoing hysterectomy.

Participants were allocated to an intervention group or a control group. The intervention group received TENS in addition to routine postoperative care, while the control group received routine postoperative care.

TENS was administered during two sessions, approximately 5-6 hours and 13-14 hours after surgery. Each session lasted 20 minutes. Stimulation was delivered at a frequency of 100 Hz, with a pulse duration of 40-60 microseconds. Four electrodes were positioned around the surgical incision.

Postoperative mobility was evaluated using patient- and observer-rated mobility measures. Anxiety was assessed using an anxiety assessment scale, and quality of recovery was measured using the Quality of Recovery-40 (QoR-40) questionnaire.

The study investigated whether TENS could serve as a supportive, non-pharmacological intervention during early recovery following hysterectomy.

02

Conditions studied

  • Hysterectomy

Keywords

  • Transcutaneous Electrical Nerve Stimulation
  • Postoperative Mobility
  • Postoperative Anxiety
  • Quality of Recovery
  • Gynecological Surgery
03

In context

Lead sponsor

Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:- Women aged 18 years and over,

  • Who had undergone elective hysterectomy,
  • Who were able to communicate,
  • Who could read and understand Turkish,
  • Women who volunteered to take part in the study were included.

Exclusion Criteria:- Women with open wounds, infected areas or severe dermatological lesions,

  • Women with severe cardiac arrhythmia,
  • Women who had used opioids, or psychoactive medication prior to the procedure were excluded from the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    TENS Group

    Participants in the intervention group received transcutaneous electrical nerve stimulation (TENS) in addition to routine postoperative care following hysterectomy. TENS was administered in two 20-minute sessions at 5-6 and 13-14 hours after surgery. Kopyala

    Device: Transcutaneous Electrical Nerve Stimulation (TENS)

  • No intervention
    Control Group

    Participants in the control group received routine postoperative care following hysterectomy. No transcutaneous electrical nerve stimulation (TENS) was administered. Participants underwent the same scheduled outcome assessments as the experimental group.

Interventions

  • DeviceTranscutaneous Electrical Nerve Stimulation (TENS)

    Participants received transcutaneous electrical nerve stimulation (TENS) using a Globus device in addition to routine postoperative care. TENS was administered in two 20-minute sessions at 5-6 and 13-14 hours after hysterectomy. The stimulation frequency was 100 Hz, with a pulse duration of 40-60 microseconds. Four electrodes were placed transversely, approximately 2 cm above and below the surgical incision.v

06

What researchers measure

Primary outcomes

  1. Patient Mobility Scale

    The Patient Mobility Scale assesses patients' perceived difficulty during four postoperative mobility activities. Each activity is rated using a 15-cm visual analogue scale. Higher scores indicate greater difficulty with mobility.

    Time frame: Postoperatively, immediately before and after each TENS session at 5-6 and 13-14 hours after surgery (four assessments).

  2. Observer Mobility Scale (OMS)

    The Observer Mobility Scale assesses the patient's level of independence during four postoperative mobility activities. Each activity is scored from 1 to 5. The total score ranges from 4 to 20, with higher scores indicating greater dependence and difficulty performing mobility activities.

    Time frame: Postoperatively, immediately before and after each TENS session at 5-6 and 13-14 hours after surgery (four assessments).

  3. Anxiety Assessment Scale (AAS)

    The Anxiety Assessment Scale consists of 10 items across three dimensions: physiological tension, worry, and lack of security. The total score ranges from 10 to 50, with higher scores indicating higher levels of anxiety.

    Time frame: Postoperatively, immediately before and after each TENS session at 5-6 and 13-14 hours after surgery (four assessments).

  4. Quality of Recovery-40 (QoR-40)

    The Quality of Recovery-40 questionnaire consists of 40 items covering five dimensions: physical comfort, emotional state, patient support, physical independence, and pain. Total scores range from 40 to 200, with higher scores indicating better postoperative recovery quality.

    Time frame: Postoperatively, immediately before and after each TENS session at 5-6 and 13-14 hours after surgery (four assessments).

07

Study locations

1 site
  • Inonu University
    Malatya, BATTALGAZİ 44280, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared publicly due to participant confidentiality and privacy considerations. There is no established plan for sharing de-identified individual participant data with other researchers.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2026 to primary completion in Aug 2026, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartActual
Apr 20, 2026
Primary completionActual
Aug 28, 2026
CompletionActual
Aug 28, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921524
Lead sponsor
Inonu University
Responsible party
ŞEYMA KARABULUT BOZAL (Assistant Professor, Inonu University) — Principal investigator
First posted
Nov 6, 2026
Start date
Apr 20, 2026
Primary completion
Aug 28, 2026
Completion
Aug 28, 2026
Last update
Nov 6, 2026

Study contacts

SÜMEYYE ALTIPARMAK, PhD
principal investigator · Inonu University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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