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IRCT20230130057284N1 IRCT 2023-03-02 Shahid Beheshti University of Medical Sciences The Effect of Foot Reflexology Massage on Reducing Post Dural Puncture Headache The Effect of Foot Reflexology Massage on Reducing Post Dural Puncture Headache 2023-02-20 anticipated 70 Complete https://irct.ir/trial/68353 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: The sampling method in this study will be available and randomly limited after checking the conditions of entering the study and confirming the presence of headache after spinal anesthesia by a specialist doctor. After determining the final sample size, the samples will be divided into intervention and control groups using random allocation by card lottery. The cards are prepared with the same shape and appearance, and 35 cards with white color will belong to the intervention group and 35 cards with black color will belong to the control group. The cards will be placed in a similar envelope so that the card type is not recognized. An independent research assistant, who will only be involved in randomization, will then draw a card at random, Blinding description: In this study, participating patients do not know which group they belong to. N/A Post Dural Puncture Headache. Intervention group: In the intervention group, foot massage will be performed on headache points for 30 minutes (15 minutes for each foot). In the control group, only a simple exfoliation massage will be performed on the soles and feet for 6 minutes (3 minutes each foot). Yes - There is a plan to make this available What will be shared: After the collection and statistical analysis, all the variables in the research can be shared and the personal information of the participants is confidential When: Probably the end of the year 2023 To whom: University researchers, university professors and nursing students Conditions: If the principles of research ethics have been observed and proceeded according to the principles Where to obtain: Email: narges_mahdavi@sbmu.ac.ir Narges Mahdavi contact number 00989368347114 Email: m_ilkhani@sbmu.ac.ir Dr. Mahnaz Ilkhani contact number 00989123131526 How to obtain: In this research, sampling takes about 2 months, after that one month is considered for statistical analysis and then the writing of the article begins. In total, this collection takes about 6 to 8 months Comments:
public Narges Mahdavi
Alzahra girls dormitory, Vali Asar Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 narges_mahdavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mahnaz Ilkhani
Vali Asar Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 m_ilkhani@ sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients between 20 and 60 years of age who undergo surgery using spinal anesthesia Being alert and aware of time and place Being literate in reading and writing Only one attempt has been made to access the subarachnoid space Not receiving painkillers three hours before the intervention Absence of addiction, due to the effect of drugs on the pain tolerance threshold of patients 20 years 60 years Both Having a history of chronic headache Patients with a history of underlying diseases (having hypertension, neuromuscular diseases) Unwillingness to continue participating in the study Clearance before 24 hours Acute infectious diseases during the study Treatment - Other Intervention group: In the intervention group, foot massage will be performed on headache points for 30 minutes (15 minutes for each foot). In the control group, only a simple exfoliation massage will be performed on the soles and feet for 6 minutes (3 minutes each foot) Headache Intensity Score. Timepoint: 30 minutes of massage in the intervention group for two days immediately and 90 minutes after the intervention. Method of measurement: Visual Analogue Scale. Duration of headache. Timepoint: 30 minutes of massage in the intervention group for two days immediately and 90 minutes after the intervention. Method of measurement: Visual Analogue Scale. The amount of housing received. Timepoint: In the entire duration of the intervention. Method of measurement: Housing check list. Shahid Beheshti University of Medical Sciences Approved 2022-05-24 Ethics committee of Shahid Beheshti University of Medical Sciences Vali Asar Ave Tehran Tehran Iran (Islamic Republic of)