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The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery

Primary Purpose

Mothers

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
case and control group
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mothers focused on measuring Knitting, anxiety, hernia, art therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers
  • Inclusion criteria in the study;

    1. Mothers know how to knit,
    2. Mothers' willingness to participate in the study,
    3. The child has not had a previous surgical operation.
    4. The mother has not had any psychological trauma or psychiatric diagnosis in the last six months.

exclusion criteria in the study;

  1. Mothers do not know how to knit,
  2. Refusal of mothers to participate in research,
  3. The child has had previous surgery,
  4. The mother's history of any psychological trauma or psychiatric diagnosis in the last six months.

Sites / Locations

  • Health Sciences Universyt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

case group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anxiety Levels of Mothers
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Anxiety Levels of Mothers
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Heartbeat of mothers
heartbeat per minutes
Heartbeat of mothers
heartbeat per minutes
Breathing rate of mothers
breathing rate per minutes
Breathing rate of mothers
breathing rate per minutes
Blood pressure of mothers
blood pressure in mmHg
Blood pressure of mothers
blood pressure in mmHg
Oxygen saturation of mothers
oxygen saturation in percent
Oxygen saturation of mothers
oxygen saturation in percent

Secondary Outcome Measures

Full Information

First Posted
January 14, 2021
Last Updated
April 30, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05141162
Brief Title
The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery
Official Title
The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mothers
Keywords
Knitting, anxiety, hernia, art therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
case group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
case and control group
Intervention Description
randomized controlled experimental study
Primary Outcome Measure Information:
Title
Anxiety Levels of Mothers
Description
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Time Frame
15 minutes after the start of surgery
Title
Anxiety Levels of Mothers
Description
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Time Frame
1 hour after the start of surgery
Title
Heartbeat of mothers
Description
heartbeat per minutes
Time Frame
15 minutes after the start of surgery
Title
Heartbeat of mothers
Description
heartbeat per minutes
Time Frame
1 hour after the start of surgery
Title
Breathing rate of mothers
Description
breathing rate per minutes
Time Frame
15 minutes after the start of surgery
Title
Breathing rate of mothers
Description
breathing rate per minutes
Time Frame
1 hour after the start of surgery
Title
Blood pressure of mothers
Description
blood pressure in mmHg
Time Frame
15 minutes after the start of surgery
Title
Blood pressure of mothers
Description
blood pressure in mmHg
Time Frame
1 hour after the start of surgery
Title
Oxygen saturation of mothers
Description
oxygen saturation in percent
Time Frame
15 minutes after the start of surgery
Title
Oxygen saturation of mothers
Description
oxygen saturation in percent
Time Frame
1 hour after the start of surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Research evidence shows that especially mothers have a high level of anxiety during surgery.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Health Sciences Universyt
City
İ̇stanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30243867
Citation
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.
Results Reference
background
PubMed Identifier
28544343
Citation
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.
Results Reference
background
PubMed Identifier
30857405
Citation
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.
Results Reference
background
PubMed Identifier
22989300
Citation
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.
Results Reference
background

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The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery

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