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CompletedNCT05959785Updated Feb 19, 2025

Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.

An interventional study of Basic and light cervical mobilization exercises and Abdominal or diaphragmatic breathing exercises in Hysterectomy, sponsored by University of Seville. Completed at 2 sites in Spain. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-19.

Sponsored by University of Seville · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy.

Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.

02

Conditions studied

  • Hysterectomy

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Keywords

  • pain
  • phrenic nerve
  • shoulder
  • laparoscopy
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 74 is close to the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

University of Seville is the lead sponsor of 129 studies on the registry; 38 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Patients who have given their consent to participate in the project by signing the informed consent.

      • Patient between 18 and 65 years of age.
      • Patients with a hysterectomy scheduled to be performed in less than 3 months at the Women's Hospital in Seville or at the Quirón Sagrado Corazón Clinic in Seville.
      • Who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy.
      • Patients who are able to communicate in Spanish or English.

Exclusion criteria

Exclusion Criteria:

  • Neurological Pathology.
  • Non-cooperative Subject.
  • Severe Psychiatric Illness.
  • Loss of Cognitive Capacity.
  • Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs.
  • Localized pain in areas not considered in this study and that may affect the performance and results of the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    intervention group

    Assignment to the intervention group will be done by simple randomization of the sample. A random sequence of numbers will be generated using the statistical program SPSS v.28. Patients will be included in the intervention group of each subcategory if their subject number matches one of the random numbers generated.The intervention groups will receive an explanatory video where a study collaborator performs a series of abdominal or diaphragmatic breathing exercises, which are intended to assess their effectiveness in this clinical trial.

    Procedure: Abdominal or diaphragmatic breathing exercises

  • Placebo comparator
    control groups

    The patients belonging to the control groups of each subcategory will also receive an explanatory video with basic and light cervical mobilization exercises (Annex 12). This group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours.

    Procedure: Basic and light cervical mobilization exercises

Interventions

  • ProcedureBasic and light cervical mobilization exercises

    This group of exercises will be made up of a series of cervical mobilization exercises that are performed without pain, smooth, controlled by the patients, and without forcing the angulations. They are performed seated, with the arms extended along the body and forearms and hands resting on the legs. The chair must be firm and comfortable. Head movements to the right and left, right and left lateral flexion of the cervical region, cervical flexion and extension will be performed. This exercise will be performed for 5 minutes 3 times a day and beginning in the first 24 postoperative hours.

    Also known as: Control group

  • ProcedureAbdominal or diaphragmatic breathing exercises

    The first abdominal or diaphragmatic breathing exercises will be carried out in a lying position, with the back well supported on a comfortable and firm surface, and with hips and knees flexed and feet supported. The patients take deep breaths, taking air raising the abdomen towards the ceiling, without raising the back from the horizontal plane. During expiration the navel will lower posteriorly and rise towards the thoracic region. For the second abdominal or diaphragmatic breathing exercise, the patient is seated on a firm and comfortable surface, with hips and knees flexed and feet supported. An inspiratory movement will be made in which the patient's navel will be moved outward, away from the spine. During expiration, the navel will go in the direction of the patient's spine and will rise in the direction of the thorax.

    Also known as: Intervention group

06

What researchers measure

Primary outcomes

  1. The McGill Pain Questionnaire

    Location of pain: which is usually represented by a schematic figure of the human body, where the patient points out the areas where they feel pain. * Quality of pain: the patient must choose from a wide list of types of pain those characteristics that define the one he presents. They are grouped into various categories that in turn form four large groups: sensory, emotional, evaluative and miscellaneous. In the original English version, the number of words was 78, although they may vary in the different validations of the questionnaire (66 in the Spanish version). * Pain intensity at the current moment: explored by means of a question with five possible response categories. * Assessment of pain at the current time using a visual analogue scale, ranging from "no pain" to "unbearable pain".

    Time frame: 24 hours after laparoscopy

  2. The Brief Pain Questionnaire

    This questionnaire, in its short version, includes a body map that the patient can use to mark the areas where pain is located. In addition to providing a useful tool for localizing pain, this questionnaire provides important information about other characteristics of pain, as well as response to prescribed treatments.

    Time frame: 24 hours after laparoscopy

  3. The Quick Dash quiz

    Questionnaire containing questions about symptoms and the ability to use instruments of the upper limbs. Collect data referring to the last week

    Time frame: 24 hours after laparoscopy

  4. The HIT-6 scale

    evaluates the headache through 6 questions

    Time frame: 24 hours after laparoscopy

  5. The Neck Disability Index questionnaire

    assesses neck and back pain and its influence on basic activities of daily living

    Time frame: 24 hours after laparoscopy

07

Study locations

2 sites
  • Hospital Universitario Virgen del Rocío
    Seville, Sevilla 41013, Spain
  • Quiron Sagrado Corazon
    Seville, Sevilla 41013, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in Jun 2024, 16 months.

Of 1,253 non-industry interventional studies with no phase under Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 29. This study's 16 months is above that.

Counting every sponsor, half of 1,276 studies reached it within 11 months; a quarter within 5 and three quarters within 30.

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

Registered
Mar 30, 2023
First posted
Jul 25, 2023
StartActual
Feb 2, 2023
Primary completionActual
Jun 15, 2024
CompletionActual
Feb 10, 2025
Last update
Feb 19, 2025
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.
No changes since tracking began. The registry record was last updated on Feb 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05959785
Responsible party
Antonio Luis Partida Márquez (Diplomado en Enfermería, University of Seville) — Principal investigator
First posted
Jul 25, 2023
Start date
Feb 2, 2023
Primary completion
Jun 15, 2024
Completion
Feb 10, 2025
Last update
Feb 19, 2025

Oversight

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

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