MothersNCT05141162
The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery
A study of Mothers, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mothers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mothers
- Being tested
- case and control group
- Keywords
- Knitting, anxiety, hernia, art therapy
- Medical subject headings
- Anxiety Disorders, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case and control groupBehavioural
randomized controlled experimental study
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | 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. Receives: Behavioral: case and control group |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Levels of Mothers
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Measured: 15 minutes after the start of surgery
Anxiety Levels of Mothers
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Measured: 1 hour after the start of surgery
Heartbeat of mothers
heartbeat per minutes
Measured: 15 minutes after the start of surgery
Heartbeat of mothers
heartbeat per minutes
Measured: 1 hour after the start of surgery
Breathing rate of mothers
breathing rate per minutes
Measured: 15 minutes after the start of surgery
Breathing rate of mothers
breathing rate per minutes
Measured: 1 hour after the start of surgery
Blood pressure of mothers
blood pressure in mmHg
Measured: 15 minutes after the start of surgery
Blood pressure of mothers
blood pressure in mmHg
Measured: 1 hour after the start of surgery
Oxygen saturation of mothers
oxygen saturation in percent
Measured: 15 minutes after the start of surgery
Oxygen saturation of mothers
oxygen saturation in percent
Measured: 1 hour after the start of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start24 Nov 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MothersStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzide Özden AKCAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141162
- Sponsor's protocol ID
- anxiety and knitting
- Status last verified
- Apr 2023
- First submitted
- 14 Jan 2021
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30243867Pomicino 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.
PubMed 28544343Brooks 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.
PubMed 30857405Pollanen 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.
PubMed 22989300
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Knitting on Mothers' Anxiety Levels During Pediatric Hernia Surgery
- ClinicalTrials.gov ID
- NCT05141162
- Acronym / sponsor ID
- anxiety and knitting
- Conditions
- Mothers
- Keywords
- Knitting, anxiety, hernia, art therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Behavioral: case and control groupIn 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| case and control grouprandomized controlled experimental study | Behavioural | case group |
Primary outcome
Anxiety Levels of Mothers
Time frame: 15 minutes after the start of surgery
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Anxiety Levels of Mothers
Time frame: 1 hour after the start of surgery
Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.
Heartbeat of mothers
Time frame: 15 minutes after the start of surgery
heartbeat per minutes
Heartbeat of mothers
Time frame: 1 hour after the start of surgery
heartbeat per minutes
Breathing rate of mothers
Time frame: 15 minutes after the start of surgery
breathing rate per minutes
Breathing rate of mothers
Time frame: 1 hour after the start of surgery
breathing rate per minutes
Blood pressure of mothers
Time frame: 15 minutes after the start of surgery
blood pressure in mmHg
Blood pressure of mothers
Time frame: 1 hour after the start of surgery
blood pressure in mmHg
Oxygen saturation of mothers
Time frame: 15 minutes after the start of surgery
oxygen saturation in percent
Oxygen saturation of mothers
Time frame: 1 hour after the start of surgery
oxygen saturation in percent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Background: PubMed 30243867Kumar 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.
- Background: PubMed 28544343Pomicino 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.
- Background: PubMed 30857405Brooks 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.
- Background: PubMed 22989300Pollanen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mothers, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Levels of Mothers (time frame: 15 minutes after the start of surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05141162, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.