<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20240905062955N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-14</date_registration>
      <primary_sponsor>Islamic Azad University, Semnan branch</primary_sponsor>
      <public_title>Investigating the effectiveness of parental cognitive hypnotherapy on impulsivity, aggression and improving the parent-child relationship</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effectiveness of parental cognitive hypnotherapy on impulsivity, aggression and improving the parent-child relationship</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78870</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, randomization method is used to assign samples to intervention and control groups. First, each participant receives a unique ID. These IDs are randomly written on cards and the cards are thrown into a large container. Then, the cards are shuffled and taken out in turn. Each ID is randomly assigned to different groups. To determine the intervention and control groups, the set of cards is divided into two groups and each group is randomly assigned to one of the groups. This process ensures that the allocation of participants to groups is done without prejudice and randomly, which reduces the possibility of bias in the research results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parent-child relationships.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this research, cognitive hypnotherapy intervention based on Aladdin's protocol (2007) will be implemented in 8 sessions of one and a half hours, twice a week for one month, as a group for mothers and their children. Each session includes mental relaxation techniques and hypnotherapy inductions, along with cognitive exercises to improve impulse control and reduce aggression. Also, the focus is on strengthening healthy parent-child communication and increasing self-awareness. Home exercises are provided between sessions to consolidate learning. The main goal of this intervention is to reduce impulsivity and aggression and improve the parent-child relationship.strengthening healthy parent-child communication and increasing self-awareness. Home exercises are provided between sessions to consolidate learning. The main goal of this intervention is to reduce impulsivity and aggression and improve the parent-child relationship. Intervention 2: Control group: It usually receives no intervention and serves as a comparison group. In other words, the control group only received usual and standard care and did not benefit from the CPRT cognitive program.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The stages of the clinical study, such as the number of participants, the criteria for entering and exiting the research project, the sampling method, the treatment protocol, and the results of the study will be described in the thesis and article.

When:
The data can be made available one month after the results are published.

To whom:
Study data and documentation will be available to researchers and researchers working in accredited academic and scientific institutions. These people can access the data by submitting a request and after reviewing and approving the request. In addition, researchers who are working in the industry related to the research topic can also apply to receive data and documentation, provided that their request is approved. The purpose of these restrictions is to ensure the responsible and ethical use of research data and documentation.

Conditions:
In order to study or conduct research by mentioning the source.

Where to obtain:
If you need data, contact as.m7.moradisetayesh@gmail.com.

How to obtain:
After receiving the request and reviewing it by the main researcher, the data will be sent to the requester within a week, along with a letter of commitment stating that the data will not be published without the name of the main researcher and that the privacy and confidentiality of the research participants will be preserved.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Setayesh Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 3rd floor, Shamshad 1 Alley, Sharifi Blvd, Hasanabad Fashafoye, Shahrari.</address>
        <city>Shahrari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1833136977</zip>
        <telephone>+98 21 5622 9143</telephone>
        <email>as.m7.moradisetayesh@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Daood Nodehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513137111</zip>
        <telephone>+98 23 3365 4040</telephone>
        <email>davud.nodehi@gmail.com</email>
        <affiliation>Islamic Azad University, Semnan branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirming the diagnosis of parents' impulsivity or aggression based on standard questionnaires
Report problems with the child, such as lack of effective communication or frequent conflicts
The age range is 25 to 45 years for mothers and 8 to 10 years for children.
Parents should be willing to attend regular hypnotherapy sessions
At the time of entering the research, parents should not use drugs that affect hypnotherapy (such as sedatives or anti-anxiety drugs).
Parents must be in good physical health and no chronic illness prevents them from participating in the meetings.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Parents who do not want to participate regularly in hypnotherapy sessions or do not participate in research sessions.
Starting to take sedatives, anti-anxiety drugs or other drugs that affect the results of hypnotherapy.
In the event of events such as separation of parents or relocation that can affect the parent-child relationship.
If the parents have serious psychiatric problems such as severe depression, bipolar disorder, or psychotic disorders that prevent continued hypnotherapy treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z62</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Problems related to upbringing</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this research, cognitive hypnotherapy intervention based on Aladdin's protocol (2007) will be implemented in 8 sessions of one and a half hours, twice a week for one month, as a group for mothers and their children. Each session includes mental relaxation techniques and hypnotherapy inductions, along with cognitive exercises to improve impulse control and reduce aggression. Also, the focus is on strengthening healthy parent-child communication and increasing self-awareness. Home exercises are provided between sessions to consolidate learning. The main goal of this intervention is to reduce impulsivity and aggression and improve the parent-child relationship.strengthening healthy parent-child communication and increasing self-awareness. Home exercises are provided between sessions to consolidate learning. The main goal of this intervention is to reduce impulsivity and aggression and improve the parent-child relationship.</i_keyword>
      <i_keyword>Control group: It usually receives no intervention and serves as a comparison group. In other words, the control group only received usual and standard care and did not benefit from the CPRT cognitive program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggression. Timepoint: Before starting the intervention (pre-test) and after completing 8 intervention sessions (post-test). Method of measurement: Shahim Aggression Questionnaire (2016).</prim_outcome>
      <prim_outcome>Impulsivity. Timepoint: Before starting the intervention (pre-test) and after completing 8 intervention sessions (post-test). Method of measurement: Hirschfield et al.'s impulsivity scale (1965).</prim_outcome>
      <prim_outcome>Parent-child relationship. Timepoint: Before starting the intervention (pre-test) and after completing 8 intervention sessions (post-test). Method of measurement: Pianta Parent-Child Relationship Questionnaire (1994).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University, Semnan branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-01</approval_date>
        <contact_name>Ethics Committee of Semnan Azad University</contact_name>
        <contact_address>Islamic Azad University, University Town, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
