Pain, AcuteNCT03072888
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy
A study testing TENS in people with Pain, Acute, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Pain, Acute
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2016to 5 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between18-65 undergoing elective abdominal hysterectomy
- ASA (American Society of Anesthesiologist) I,II physical status
Who cannot join
- Not agreement with the study,Dermatological lesion affecting the electrode place,
- Chronic or preprocedural use of opioids, steroids or psychoactive drugs,
- Allergy to drugs used during trials,
- Previous experience in TENS,
- Kidney, liver, neurological or cardiovascular system disease
- Body mass index>40
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Medical School
Tokat Province, 60100
About this study
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Recovery After Abdominal Hysterectomy
The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery.
Read the detailed description
The aim of this study is to evaluate the efficacy of the Transcutaneous Electrical Nerve Stimulation (TENS) on postoperative pain and quality of recovery in patients following abdominal hysterectomy surgery under general anesthesia.
- Conditions
- Pain, Acute
- Being tested
- TENS
- Keywords
- acute pain, Transcutaneous Electric Nerve Stimulation, Anesthesia Recovery Period
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called Transcutaneous Electrical Nerve Stimulation
Transcutaneous Electrical Nerve Stimulation will be apply
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | TENS treatment will be apply with 30 minutes sessions seven times per day at the intensity between 9-15 milliamps (mA) which will be adjusted depending on the sensitivity of each individual patient. Receives: Device: TENS |
| Control | Sham comparator | Patients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery
QoR-40 (Quality of Recovery 40) form will be used for evaluation
Measured: At twenty-four hours after surgery
Secondary outcomes (3)
Pain
Dynamic and static pain will be evaluated by visual analog scale(VAS)
Measured: During 24 hours after surgery
Analgesic Consumption
Total consumption of analgesic will be recorded
Measured: During 24 hours after surgery
Postoperative Nausea and Vomiting
Nausea and Vomiting scores will be recorded
Measured: During 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start31 Mar 2016
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072888
- Sponsor's protocol ID
- TENS
- Status last verified
- May 2017
- First submitted
- 20 Feb 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Quality of Recovery After Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT03072888
- Acronym / sponsor ID
- TENS
- Conditions
- Pain, Acute
- Keywords
- acute pain, Transcutaneous Electric Nerve Stimulation, Anesthesia Recovery Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve Stimulation (TENS) in patients after abdominal hysterectomy surgery.
Detailed description
The aim of this study is to evaluate the efficacy of the Transcutaneous Electrical Nerve Stimulation (TENS) on postoperative pain and quality of recovery in patients following abdominal hysterectomy surgery under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: TENSTENS treatment will be apply with 30 minutes sessions seven times per day at the intensity between 9-15 milliamps (mA) which will be adjusted depending on the sensitivity of each individual patient. |
| Control | Sham comparator | Device: TENSPatients will receive 30 minutes sessions seven times per day of sham TENS therapy without the intensity impulse. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between18-65 undergoing elective abdominal hysterectomy
- ASA (American Society of Anesthesiologist) I,II physical status
Key exclusion criteria (6 listed)
- Not agreement with the study,Dermatological lesion affecting the electrode place,
- Chronic or preprocedural use of opioids, steroids or psychoactive drugs,
- Allergy to drugs used during trials,
- Previous experience in TENS,
- Kidney, liver, neurological or cardiovascular system disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSAlso: Transcutaneous Electrical Nerve StimulationTranscutaneous Electrical Nerve Stimulation will be apply | Device | Control, TENS |
Primary outcome
Quality of Recovery
Time frame: At twenty-four hours after surgery
QoR-40 (Quality of Recovery 40) form will be used for evaluation
3 secondary outcomes
Pain
Time frame: During 24 hours after surgery
Analgesic Consumption
Time frame: During 24 hours after surgery
Postoperative Nausea and Vomiting
Time frame: During 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Pain, Acute, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (time frame: At twenty-four hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.