]>
IRCT20240731062603N1 IRCT 2024-08-09 Self Comparative effects of diaphragmatic myofascial release versus diaphragmatic breathing in post operative patients diagnosed with Gastroesophaegeal reflux disease (GERD) Comparative effects of diaphragmatic myofascial release versus diaphragmatic breathing in post operative patients diagnosed with Gastroesophaegeal reflux disease (GERD) 2024-08-08 anticipated 28 Complete https://irct.ir/trial/78257 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Lottery method was used. subjects were distributed in the groups randomly. The lottery method of randomization is a technique used to randomly assign participants or items to different groups or conditions. Here's a step-by-step description of the process: 1.Identification of participants or items: Identify the individuals or items that need to be randomized. 2. Assignment of unique identifiers: Assign a unique identifier (e.g., number, code, or name) to each participant or item. 3. Creation of a lottery pool: Create a pool of unique identifiers, similar to a lottery drawing. 4. Random drawing: Randomly draw identifiers from the pool, using a method such as a random number generator or a physical drawing. 5. Assignment to groups: Assign the drawn identifiers to different groups or conditions, based on the random order in which they were drawn. 6. Repeat the process: Continue drawing and assigning identifiers until all participants or items have been assigned to a group. The lottery method ensures that: - Each participant or item has an equal chance of being assigned to any group. - The assignment is random and unbiased. - The process is transparent, Blinding description: Participants were unaware of the intervention which was applied.Assesor was unaware of the group of interventions. N/A Gastroesophaegeal reflux disease. Intervention 1: Group 1: DB Group Number of participants: [14]- Gender: [Both]-Intervention:Type: Diaphragmatic breathing exercises- Frequency: 2 times a week- Duration: 2 weeks- Number of repetitions: 25 repetitions per session- Exercise Protocol:1. Participants sit comfortably with their backs straight, feet planted firmly on the ground, and hands placed gently on their stomach.2. Inhale deeply through the nose, allowing the diaphragm to drop and the stomach to rise as the lungs fill with air (count of 4).3. Hold the breath for a brief moment (count of 2).4. Exhale slowly through the mouth, allowing the diaphragm to rise and the stomach to fall as the lungs empty (count of 4).5. Repeat for 25 repetitions.Instructions:Participants are instructed to focus on the sensation of their diaphragm expanding and contracting.- Encourage participants to breathe naturally and avoid forcing their breathing.- Monitor participants for proper technique and provide feedback as needed. Intervention 2: Group 2 : Diaphragmatic Myofascial release group: Group Characteristics:_- Number of participants: [14]- Age range: [25 to 45 yrs]- Gender: [both] Health status: Diagnosed with Gastroesophageal Reflux Disease (GERD)_Intervention:Type: Diaphragmatic myofascial release- Frequency: 2 times a week- Duration: 2 weeks- Number of repetitions: 10 repetitions per session-Technique:_1. Participants lie on their back with knees bent and feet flat on the floor.2. The practitioner applies gentle, sustained pressure to the diaphragm using their fingers or a tool.3. Pressure is held for 3-5 minutes to release tension in the diaphragm and surrounding fascia.4. Participants breathe deeply and naturally during the release.5. Repeat for 10 repetitions.Goals:Reduce the severity of GERD symptoms- Improve diaphragmatic function and mobility- Enhance digestion and reduce discomfort_Outcome Measures:_- GERD symptom severity (e.g., frequency, duration, intensity)- Quality of life questionnaires (e.g., GERD-QOL)_Theoretical Rationale:Diaphragmatic tension can contribute to GERD symptoms by increasing intra-abdominal pressure and impairing esophageal function.- Myofascial release can help relax the diaphragm, improve its function, and reduce GERD symptoms.This description provides a clear outline of the group's characteristics, the intervention, and the technique used to reduce the severity of GERD symptoms. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Nothing decided yet
public Fizzah Tahir
P 58 street no 3 Umar block Muslim town 1 Sargodha road Faisalabad
Faisalabad Pakistan 44444 +92 318 7411248 fizzahtahir2k19@gmail.com The University of Faisalabad scientific Fizzah Tahir
P 58 street no 3 Umar block Muslim town 1 Sargodha road Faisalabad
Faisalabad Pakistan 44444 +92 318 7411248 fizzahtahir2k19@gmail.com The University of Faisalabad Pakistan Both genders,age 25 to 45 years Willingness to participate Participants with stable cardiovascular and respiratory system Confirmed diagnosis of GERD 1 week after surgery 25 years 45 years Both Diagnosed Febrile illness Diagnosed malignancy Diagnosed psychiatric disorder Gastroesop Gastroesophaegeal reflux disease Treatment - Other Treatment - Other Group 1: DB Group Number of participants: [14]- Gender: [Both]-Intervention:Type: Diaphragmatic breathing exercises- Frequency: 2 times a week- Duration: 2 weeks- Number of repetitions: 25 repetitions per session- Exercise Protocol:1. Participants sit comfortably with their backs straight, feet planted firmly on the ground, and hands placed gently on their stomach.2. Inhale deeply through the nose, allowing the diaphragm to drop and the stomach to rise as the lungs fill with air (count of 4).3. Hold the breath for a brief moment (count of 2).4. Exhale slowly through the mouth, allowing the diaphragm to rise and the stomach to fall as the lungs empty (count of 4).5. Repeat for 25 repetitions.Instructions:Participants are instructed to focus on the sensation of their diaphragm expanding and contracting.- Encourage participants to breathe naturally and avoid forcing their breathing.- Monitor participants for proper technique and provide feedback as needed. Group 2 : Diaphragmatic Myofascial release group: Group Characteristics:_- Number of participants: [14]- Age range: [25 to 45 yrs]- Gender: [both] Health status: Diagnosed with Gastroesophageal Reflux Disease (GERD)_Intervention:Type: Diaphragmatic myofascial release- Frequency: 2 times a week- Duration: 2 weeks- Number of repetitions: 10 repetitions per session-Technique:_1. Participants lie on their back with knees bent and feet flat on the floor.2. The practitioner applies gentle, sustained pressure to the diaphragm using their fingers or a tool.3. Pressure is held for 3-5 minutes to release tension in the diaphragm and surrounding fascia.4. Participants breathe deeply and naturally during the release.5. Repeat for 10 repetitions.Goals:Reduce the severity of GERD symptoms- Improve diaphragmatic function and mobility- Enhance digestion and reduce discomfort_Outcome Measures:_- GERD symptom severity (e.g., frequency, duration, intensity)- Quality of life questionnaires (e.g., GERD-QOL)_Theoretical Rationale:Diaphragmatic tension can contribute to GERD symptoms by increasing intra-abdominal pressure and impairing esophageal function.- Myofascial release can help relax the diaphragm, improve its function, and reduce GERD symptoms.This description provides a clear outline of the group's characteristics, the intervention, and the technique used to reduce the severity of GERD symptoms. It was measured by reflux disease questionnaire that is self-administered questionnaire comprising 12 items which will measure the frequency and severity of heart burn, regurgitation and dyspeptic complaints which was experienced in early weeks after surgery. Timepoint: 15 days. Method of measurement: Reflux disease Questionaire (RDQ). It had brought changes in health related quality of life through Gastrointestinal symptom rating scale (GSRS). Timepoint: 15 days. Method of measurement: Gastrointestinal symptom rating score GSRS. Self Approved 2024-02-19 The University of Faisalabad Sargodha road Faisalabad Faisalabad Punjab Pakistan