- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141162
The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery
Regardless of the type of surgical intervention, it is a negative life experience for the child and family members and is known to cause anxiety. Having a surgical incision in the child's body and the likelihood of developing conditions such as pain, organ loss or death, change in the parental role, and the hospital environment are situations that increase the stress of the parents. Hernia is the most common surgical pathology in children. Hernias are also risky in terms of complications.
Parents' experiencing severe anxiety may prevent their ability to understand the child's explanations correctly, interpret events realistically, make correct decisions, participate in the care of the child, and use appropriate coping methods. Parents abandon their habitual attitudes because they feel anxiety and sadness. Their tolerance increases and, as a result, they do whatever their children want. This change in the attitudes of the parents may increase the anxiety of the child and make him feel more sick than he is. Therefore, it is very important for the child to reduce the parent's anxiety.
At the pathological level, anxiety requires pharmacological and / or psychosocial intervention. The main purpose of psychosocial intervention is to understand and discover one's emotions. Some authors mention the benefits of using expressive methods. Art practices are at the top of the expressionist methods, and according to the nursing interventions classification system (NIC), art therapy is among the nursing interventions.
Study Overview
Detailed Description
Studies have shown that art practices reduce women's stress, anxiety, depression and fatigue. On the other hand, occupational therapy is another example of the use of art in psychotherapy. Various crafts and decorations are made in this type of therapy.
Most of the studies on knitting in the literature have been conducted with groups, and there is no study examining the effect of knitting in reducing the anxiety of mothers whose children underwent surgery. In this study, which was planned as a randomized controlled experimental study, it was aimed to examine the effect of knitting on the anxiety levels of the mothers of children who underwent hernia surgery.
The objectives of the study; To determine the anxiety levels of mothers of children who underwent planned surgery. To determine the effects of demographic characteristics on mothers' anxiety levels. To determine the effect of knitting knitting method on the anxiety levels of the mothers of children who underwent hernia surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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İ̇stanbul, Turkey
- Health Sciences Universyt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria in the study;
- Mothers know how to knit,
- Mothers' willingness to participate in the study,
- The child has not had a previous surgical operation.
- The mother has not had any psychological trauma or psychiatric diagnosis in the last six months.
exclusion criteria in the study;
- Mothers do not know how to knit,
- Refusal of mothers to participate in research,
- The child has had previous surgery,
- The mother's history of any psychological trauma or psychiatric diagnosis in the last six months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: case group
In the first stage, an information form including socio-demographic characteristics prepared within the framework of the literature and State-Trait Anxiety Inventory will be applied to mothers before surgery.
Later, the experimental group will be knitted by the researcher during the surgical operation.
The necessary materials (knitting needle and thread) for the knitting attempt will be given to the participants in the experimental group by the researcher.
A neutral color, white, will be used as the knitting yarn color.
Knitting will start 15 minutes after the child enters the operation and will be knitted for 30-40 minutes on average.
At the end of the surgery, the State-Trait Anxiety Inventory scale will be applied again to evaluate the anxiety levels of the participants in the experimental and control groups.
The vital signs of the mothers will be measured at the beginning of the operation and close to the end of the operation.
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randomized controlled experimental study
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No Intervention: control group
An information form including socio-demographic characteristics prepared within the framework of the preoperative literature and State-Trait Anxiety Inventory will be applied to mothers.
No attempt will be made to this group.
At the end of the surgery, the State Trait Anxiety Inventory scale will be applied again to evaluate the anxiety levels of the participants in the experimental and control groups.
The vital signs of the mothers will be measured at the beginning of the operation and near the end of the operation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Anxiety Levels of Mothers
Time Frame: 15 minutes after the start of surgery
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Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
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15 minutes after the start of surgery
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Anxiety Levels of Mothers
Time Frame: 1 hour after the start of surgery
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Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
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1 hour after the start of surgery
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Heartbeat of mothers
Time Frame: 15 minutes after the start of surgery
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heartbeat per minutes
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15 minutes after the start of surgery
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Heartbeat of mothers
Time Frame: 1 hour after the start of surgery
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heartbeat per minutes
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1 hour after the start of surgery
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Breathing rate of mothers
Time Frame: 15 minutes after the start of surgery
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breathing rate per minutes
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15 minutes after the start of surgery
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Breathing rate of mothers
Time Frame: 1 hour after the start of surgery
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breathing rate per minutes
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1 hour after the start of surgery
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Blood pressure of mothers
Time Frame: 15 minutes after the start of surgery
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blood pressure in mmHg
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15 minutes after the start of surgery
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Blood pressure of mothers
Time Frame: 1 hour after the start of surgery
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blood pressure in mmHg
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1 hour after the start of surgery
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Oxygen saturation of mothers
Time Frame: 15 minutes after the start of surgery
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oxygen saturation in percent
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15 minutes after the start of surgery
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Oxygen saturation of mothers
Time Frame: 1 hour after the start of surgery
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oxygen saturation in percent
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1 hour after the start of surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kumar A, Das S, Chauhan S, Kiran U, Satapathy S. Perioperative Anxiety and Stress in Children Undergoing Congenital Cardiac Surgery and Their Parents: Effect of Brief Intervention-A Randomized Control Trial. J Cardiothorac Vasc Anesth. 2019 May;33(5):1244-1250. doi: 10.1053/j.jvca.2018.08.187. Epub 2018 Aug 22.
- Pomicino L, Maccacari E, Buchini S. Levels of anxiety in parents in the 24 hr before and after their child's surgery: A descriptive study. J Clin Nurs. 2018 Jan;27(1-2):278-287. doi: 10.1111/jocn.13895. Epub 2017 Dec 11.
- Brooks L, Ta KN, Townsend AF, Backman CL. "I just love it": Avid knitters describe health and well-being through occupation. Can J Occup Ther. 2019 Apr;86(2):114-124. doi: 10.1177/0008417419831401. Epub 2019 Mar 11.
- Pollanen S. The meaning of craft: craft makers' descriptions of craft as an occupation. Scand J Occup Ther. 2013 May;20(3):217-27. doi: 10.3109/11038128.2012.725182. Epub 2012 Sep 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- anxiety and knitting
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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