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IRCT20220704055367N3 IRCT 2022-11-04 Karaj University of Medical Sciences Comparison of the effect of deep breathing and guided visualization in children Comparative investigation of the effect of deep breathing and guided imagery on sleep quality and vital signs in children admitted to the hospital: A Randomized Controlled Trial 2022-11-24 anticipated 75 Complete https://irct.ir/trial/66547 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: By using a randomized table, children will be assigned to one of the three groups (guided imagery, deep breathing and control). Assignment Sequences are determined using a computer random number table (www.Random.com), and in order to hide the allocation, the opaque packets are numbered sequentially, Blinding description: This study is a blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers. Also, it will be specified with one of the English letters above it, which questionnaire was completed by the participants of which of the study groups; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group. N/A Condition 1: Meningitis. Condition 2: Reye's syndrome. Intervention 1: Intervention group 1: Guided imagery takes place through standard video images, storytelling and imagination.In this way, the mentioned interventions will be played in the form of headphones for children within 18 to 20 minutes each time. This intervention take place in three days in two shifts of morning and evening. The content of the audio file includes appropriate and pleasant topics combined with soothing music so that the child can visualize it in his/her mind. Intervention 2: Intervention group 2: After teaching the deep breathing technique in the form of pursed lips breathing, the child is asked to do this. Meanwhile, the researcher places one hand on the child's diaphragm to ensure the presence of air flow and starts counting with the other hand. To perform this procedure, the patient is asked to inhale and exhale in a ratio of 4:6. Patients are taught to inhale through the nose and count from one to four and exhale through the mouth and count from one to six. It will take 10-15 minutes.This intervention take place in three days in two shifts of morning and evening. Intervention 3: Control group: Receiving routine intervention of the ward such as receiving drugs, similar to other hospitalized children who will not participate in the study and will not be exposed to deep breathing or guided imagery. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome and general demographic information can be shared. When: The access period starts 3 months after the results are published To whom: Doctors, nurses, midwives, researchers working in universities and medical centers and hospitals, clinical psychologists Conditions: In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published. Where to obtain: Communication through e-mail (if possible to share information from a legal and ethical point of view, such as sharing the primary outcome of the study) To receive information, contact the following email address: fatemeh.abdi87@yahoo.com In the case of sending letter with regard to the current study, the following postal address of the corresponding author is available: School of nursing, Eshteraki street, Takhti Park, Baghestan BLVD How to obtain: Finding the responsible author's email, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester. Comments:
public Fatemeh Abdi
Taleghani Boulevard,Taleghani square ,Karaj,Iran
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3419 7000 fatemeh.abdi87@yahoo.com Karaj University of Medical Sciences scientific Fatemeh Abdi
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3433 6007 fatemeh.abdi87@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Aged between 6 to 12 Hospitalization for at least 48 hours Staying in the hospital for at least 5 days A diagnosed disease Obtaining informed consent from the child's parents 6 years 12 years Both The presence of cognitive, neurological or learning problems Having Cancer Child's lack of consciousness A87 G93.7 Viral meningitis Reye's syndrome Behavior Behavior Treatment - Drugs Intervention group 1: Guided imagery takes place through standard video images, storytelling and imagination.In this way, the mentioned interventions will be played in the form of headphones for children within 18 to 20 minutes each time. This intervention take place in three days in two shifts of morning and evening. The content of the audio file includes appropriate and pleasant topics combined with soothing music so that the child can visualize it in his/her mind. Intervention group 2: After teaching the deep breathing technique in the form of pursed lips breathing, the child is asked to do this. Meanwhile, the researcher places one hand on the child's diaphragm to ensure the presence of air flow and starts counting with the other hand. To perform this procedure, the patient is asked to inhale and exhale in a ratio of 4:6. Patients are taught to inhale through the nose and count from one to four and exhale through the mouth and count from one to six. It will take 10-15 minutes.This intervention take place in three days in two shifts of morning and evening. Control group: Receiving routine intervention of the ward such as receiving drugs, similar to other hospitalized children who will not participate in the study and will not be exposed to deep breathing or guided imagery. Sleep Quality Score. Timepoint: Before intervention and one week after intervention. Method of measurement: Pittsburgh Sleep Quality Index. Vital signs. Timepoint: Before intervention and one week after intervention. Method of measurement: 1-Blood pressure: by sphygmomanometer 2-Temperature: by thermometer 3-Pulse: counted for one full minute 4-Breathing: counted for one full minute. Karaj University of Medical Sciences Approved 2022-10-22 Research Ethics Committee of Alborz University of Medical Sciences Ethics committee office, Second floor, Safarian alley, 45 meters to Golshahr Karaj Alborz Iran (Islamic Republic of)