Back to resultsDiaphragmatic Exercises as Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.
Primary Purpose
Hysterectomy
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Basic and light cervical mobilization exercises
Abdominal or diaphragmatic breathing exercises
Sponsored by
About this trial
This is an interventional treatment trial for Hysterectomy focused on measuring pain, phrenic nerve, shoulder, laparoscopy
Eligibility Criteria
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: 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.
Sites / Locations
- Hospital Universitario Virgen del RocíoRecruiting
- Quiron Sagrado CorazonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
intervention group
control groups
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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".
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.
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
The HIT-6 scale
evaluates the headache through 6 questions
The Neck Disability Index questionnaire
assesses neck and back pain and its influence on basic activities of daily living
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05959785
Brief Title
Diaphragmatic Exercises as Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.
Official Title
Diaphragmatic Exercises as Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysterectomy
Keywords
pain, phrenic nerve, shoulder, laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial with control group and random assignment intervention
Masking
Participant
Masking Description
plain blind
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control groups
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Basic and light cervical mobilization exercises
Other Intervention Name(s)
Control group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Abdominal or diaphragmatic breathing exercises
Other Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The McGill Pain Questionnaire
Description
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
Title
The Brief Pain Questionnaire
Description
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
Title
The Quick Dash quiz
Description
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
Title
The HIT-6 scale
Description
evaluates the headache through 6 questions
Time Frame
24 hours after laparoscopy
Title
The Neck Disability Index questionnaire
Description
assesses neck and back pain and its influence on basic activities of daily living
Time Frame
24 hours after laparoscopy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Luis Partida Márquez
Phone
652985005
Email
apmolvera@gmail.com
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Luis Partida Márquez
Phone
652985005
Email
apmolvera@gmail.com
Facility Name
Quiron Sagrado Corazon
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Luis Partida Márquez
Phone
652985005
Email
apmolvera@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diaphragmatic Exercises as Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Clinical Trial.
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