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Gynecologic SurgeriesNCT06965595

The Effect of Different Physiotherapy Methods Applied After Gynecological Abdominal Surgery on Postoperative Symptoms

A study testing Routine care, Routine care + Physiotherapy and Routine care + Vagal stimulation in people with Gynecologic Surgeries and Physical Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Gynecological pelvic surgeries include procedures such as myomectomy, hysterectomy, and removal of ovarian cysts performed in the pelvic region of women. In the postoperative period following these surgeries, symptoms such as pain, decreased bowel motility, gastrointestinal problems, nausea, and vomiting are commonly… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Routine care, Routine care + Physiotherapy and Routine care + Vagal stimulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2025to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Being 18 years of age or older
  • Having undergone surgery due to a gynecological condition
  • Having undergone one of the following operations: hysterectomy, hysterectomy + oophorectomy, or hysterectomy + salpingo-oophorectomy
  • Having undergone abdominal surgery

Who cannot join

  • Development of any complications during or after surgery
  • Presence of active malignancy
  • Presence of severe organ failure
  • Presence of uncontrolled cardiac or other systemic disorders
  • Presence of neurological or cognitive diseases

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Nuh Naci Yazgan Unıversıty

    Kayseri

Other trials in Turkey (Türkiye)

About this study

Gynecological pelvic surgeries include procedures such as myomectomy, hysterectomy, and removal of ovarian cysts performed in the pelvic region of women. In the postoperative period following these surgeries, symptoms such as pain, decreased bowel motility, gastrointestinal problems, nausea, and vomiting are commonly observed. Effective management of these symptoms is important to accelerate the recovery process and improve the quality of life of patients.

This study is planned to evaluate the effectiveness of physiotherapy during the hospitalization period after gynecological abdominal surgery and to examine the effects of different approaches on postoperative symptoms.

In our study, participants who undergo gynecological abdominal surgery and meet the inclusion and exclusion criteria will be divided into four groups for intervention. In addition to routine care, interventions including physiotherapy, vagal stimulation, and a combination of physiotherapy and vagal stimulation will be applied from the postoperative period until discharge. The effects of these interventions on pain, bowel function, autonomic functions, pelvic floor function, and walking will be examined.

Read the detailed description

Gynecological pelvic surgeries refer to procedures performed in the pelvic region of women. These surgeries include procedures such as myomectomy, hysterectomy, and the removal of ovarian cysts. Surgical procedures can be performed through abdominal or vaginal routes.

Various complications may occur during or after surgical operations . In the postoperative period, complaints such as pain, decreased bowel motility (e.g., paralytic ileus) , gastrointestinal problems, nausea and vomiting, and pneumonia may occur . At the same time, the occurrence of these complaints may also lead to a decrease in the patient's level of mobility .

There are different treatment approaches for symptoms that occur in the postoperative period. In particular, pain is among the primary complaints of patients. This acute pain may lead to chronic pain and the analgesic agents used may cause side effects such as sedation, nausea, and ileus .

Physiotherapy and rehabilitation practices for gastrointestinal problems and pain in the postoperative period include applications such as breathing exercises, mobilization, and connective tissue massage .

In a study by Zia and colleagues on the effectiveness of early physiotherapy applications, cases who underwent abdominal hysterectomy were divided into two groups as control and experimental. The experimental group received a comprehensive physiotherapy rehabilitation plan including patient education, breathing exercises, early mobilization, connective tissue manipulation, and transcutaneous electrical nerve stimulation (TENS), while the control group only performed walking (ambulation). It was shown that participants in the experimental group had a faster time to first gas passage and a higher rate of defecation within the first 3 days compared to the control group. As a result of the study, it is stated that early postoperative intervention has the potential to accelerate the recovery process .

In another study, the effect of kinesio taping and breathing exercises on pain in cases undergoing gynecological abdominal surgery was examined. The researchers divided the participants into four groups: kinesio taping, breathing exercises, kinesio taping with breathing exercises, and control group, and conducted interventions for 3 days postoperatively. Time to gas passage and defecation times were evaluated, and kinesio taping was found to be the group with the best improvement in pain and the earliest gas passage time. The group that received kinesio taping and breathing exercises also showed shorter gas passage times. As a result, kinesio taping and kinesio taping with breathing exercises can be used as non-invasive methods in the postoperative period .

Recently, the vagal stimulation technique has come to the forefront among applications for pain relief . This method has also been used in individuals with complaints of constipation . Stimulation of the vagus nerve can be provided through invasive and non-invasive methods.

In a study conducted by Shi and colleagues in 2021, 42 patients with constipation-predominant irritable bowel syndrome were divided into two groups and received auricular vagal stimulation and sham vagal stimulation treatments. In this study, which examined constipation and abdominal pain, positive results such as increased bowel motility and reduced pain were obtained after 4 weeks .

In another study involving patients with chronic low back pain, 60 patients were divided into two groups to receive either conventional rehabilitation and home exercises or transcutaneous auricular vagal nerve stimulation and home exercises. At the end of the 3-week treatment program, intra-group evaluation results showed positive effects on mobility, functional status, depression, and sleep in all groups .

This study is planned to evaluate the effectiveness of physiotherapy during the hospitalization period after gynecological abdominal surgery and to examine the effects of different approaches on postoperative symptoms.

Being tested
Routine care, Routine care + Physiotherapy, Routine care + Vagal stimulation, Routine care + Physiotherapy + Vagal stimulation
Keywords
Gynecological abdominal surgery, postoperative routine care, physiotherapy and rehabilitation, vagal stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine careOther

    This group will be the control group. Routine care practices carried out in the hospital (vital sign monitoring, administration of analgesics, anti-inflammatory and antibiotics when necessary, and mobilization starting from the 6th hour) will be applied and the data will be recorded.

  • Routine care + PhysiotherapyOther

    In addition to routine care practices, this group will receive physiotherapy and rehabilitation. During the postoperative period, the intervention will be applied twice a day.

    Posture training: Information about posture will be provided in different positions and training will be conducted.

    Breathing training (Diaphragmatic breathing, thoracic expansion exercises)

    In-bed mobilization (Lower and upper extremity exercises, foot-ankle exercises (dorsiflexion-plantar flexion / inversion-eversion), hip and knee flexion-extension exercises, cervical region joint range of motion and stretching exercises, upper extremity exercises (shoulder elevation, circumduction, elbow and wrist flexion-extension exercises), pelvic floor training and exercises)

    Out-of-bed mobilization (Sitting, standing, walking training after the 6th hour)

  • Routine care + Vagal stimulationOther

    In addition to routine care practices, this group will receive vagal stimulation. The stimulation will be applied to the cervical region at 10 Hz, 200 μs for 20 minutes, twice a day.

  • Routine care + Physiotherapy + Vagal stimulationOther

    In addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.

Study groups in NCT06965595
Study groupRoleWhat they receive
Routine CareExperimentalThis group will be the control group. Routine care practices carried out in the hospital (vital sign monitoring, administration of analgesics, anti-inflammatory and antibiotics when necessary, and mobilization starting from the 6th hour) will be applied and the data will be recorded.
Receives: Other: Routine care
Rutin care + PhysiotherapyActive comparatorIn addition to routine care practices, this group will receive physiotherapy and rehabilitation. During the postoperative period, the intervention will be applied twice a day.
Receives: Other: Routine care + Physiotherapy
Routine care + vagal stimulationActive comparatorIn addition to routine care practices, this group will receive vagal stimulation. The stimulation will be applied to the cervical region at 10 Hz, 200 μs for 20 minutes, twice a day.
Receives: Other: Routine care + Vagal stimulation
Routine care + Physiotherapy + Vagal stimulationActive comparatorIn addition to routine care practices, this group will receive physiotherapy and rehabilitation, along with vagal stimulation.
Receives: Other: Routine care + Physiotherapy + Vagal stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain (VAS)

    Pain will be assessed before and after each session. Visual Analog Scale (VAS) will be used for this. Minimum value is 0 and max value is 10. Ten is a higher pain. Zero means no pain.

    Measured: Day 1 and Day 2

  2. Pain threshold measurement

    A digital algometer device will be used to determine the pain threshold.

    Measured: Baseline and Day 2

  3. Assessment of Autonomic Functions

    The recording will be made with an ECG device.R-R waves will be examined.

    Measured: Day 1 and Day 2

  4. Assessment of Autonomic Functions

    heart rate collected before and after the session.

    Measured: Day 1 and Day 2

  5. Assessment of Autonomic Functions

    Blood Pressure collected before and after the session.

    Measured: Day 1 and Day 2

  6. Assessment of Autonomic Functions

    respiratory rate collected before and after the session.

    Measured: Day 1 and Day 2

  7. Assessment of saturation (SpO₂)

    arterial oxygen saturation (SpO₂) levels of participants will be evaluated. The unit of measurement will be the percentage of oxygen saturation.

    Measured: Day 1 and Day 2

  8. Postoperative period

    The time when the first feeling of needing to pass gas time and defecation occurs will be noted.

    Measured: From enrollment to the end of treatment at 2 day

  9. The walking time

    The time of first walking will be noted.

    Measured: Postoperative

  10. First food intake

    The time of First food intake will be noted.

    Measured: Postoperative

  11. Take a medicine

    Analgesics and other medications taken will be noted.

    Measured: Day 1 and Day 2

  12. Umblikus

    Umbilicus circumference will be measured with a tape measure.

    Measured: Day 1 and Day 2

  13. xiphoid - pubis distance

    The distance between the xiphoid and pubis will be measured with a tape measure. It will be noted in cm.

    Measured: day 1 and day 2

  14. Postoperative period

    The time when the first feeling of needing to urinate occurs and the time when the feeling of micturition occurs will be noted.

    Measured: Postoperative

Secondary outcomes (9)
  1. DETAILED STORIES OF THE PATIENTS

    Participants' age, height, weight, number and status of pregnancies (gravida, abortus, dilation \& curettage, parity, number of living children, etc.), previous surgeries, medications used, comorbidities, chronic diseases, marital status, and current type of surgery will be assessed.

    Medical history, personal and family medical background, BMI, smoking habits, other lifestyle habits, and allergy status will also be evaluated.

    Measured: Before treatment

  2. Two minutes walk

    The distance she can walk in two minutes will be recorded

    Measured: Day 1 and Day 2

  3. Pelvic Floor

    To assess the condition of the pelvic floor, researchers will evaluate it using the Visual Analog Scale (VAS). This assessment will address whether the participant can feel the pelvic region, as well as the presence of pain, discomfort, or incontinence. Min value is 0 . It means no sense and max value is 10. It means high score for question.

    Measured: Day 1 and Day 2

  4. Pelvic Floor Distress Inventory-20 (PFDI-20)

    Pelvic floor symptoms will be evaluated using the Pelvic Floor Distress Inventory-20 (PFDI-20), which includes a separate subheading for these symptoms.The higher the score obtained from this questionnaire, the greater the degree of complaints about pelvic floor dysfunction.

    Measured: Day1 and Day 2

  5. Quality of Recovery-40

    It will be used to examine the recovery characteristics of the participants throughout the treatment process.Higher scores indicating higher levels of functioning or well-being.

    Measured: Day 1 and Day 2

  6. Respiratory Function Test

    It will be used to assess the patient's respiratory capacity.

    Measured: Day 1 and Day 2

  7. Patient Satisfaction

    Their satisfaction with the treatment will be evaluated.Minimum value is 0 and max value is 10. Ten is a higher satisfaction. Zero means no satisfaction.

    Measured: Day 2

  8. Mini Mental Test

    It will be used to evaluate the cognitive status item included in the exclusion criteria.

    Measured: Before treatment

  9. Operation process

    Information regarding the surgery (duration and time) will be noted.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start1 Jun 2025
  3. Primary completionApr 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06965595
Sponsor's protocol ID
2024/012/013
Status last verified
Jul 2025
First submitted
28 Mar 2025
Last updated
1 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Routine care, Routine care + Physiotherapy and Routine care + Vagal stimulation in people with Gynecologic Surgeries and Physical Therapy, run by Hacettepe 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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 1 Aug 2025. 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Postoperative Pain (VAS) (time frame: Day 1 and Day 2). The study lists 14 primary outcomes in all. 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 1 Aug 2025.

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