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PainNCT05395208

The Effect Of White Noise And Therapeutic Touch On Pain And Physiological Parameters In Premature Infants

A study testing Therapeutic touch group accompanied by white noise in people with Pain, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Newborns hospitalized with some respiratory problems in the clinic are taken to noninvasive mechanical ventilation support and vascular access is required for some treatments to be applied to these newborns. Read more about this study

Who is it for?
Ages 32 to 36 weeksHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Therapeutic touch group accompanied by white noise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2021to 12 Jan 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 32 to 36 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • To be in noninvasive mechanical ventilation support,
  • Newborns between 32-36 weeks,
  • Not having a life-threatening disease,
  • No congenital anomalies,
  • Appropriate cognitive level and motor development of the newborn,
  • The newborn does not have a physical problem,
  • Parents' willingness to participate in the research,

Who cannot join

  • Presence of IV catheter,
  • Having a condition that prevents vascular access,
  • Those who have circulation problems in the body,
  • Using narcotic, sedative opioid and anticonvulsant drugs
  • Pharmacological intervention application for the baby's pain during the procedure

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Home/Work

    Istanbul, Üsküdar, 34674

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Whıte Noıse Therapeutıc Touch On Paın Level And Physıologıcal Parameters In Perıpheral Iv Catheter Interactıon In Premature Infants

Newborns hospitalized with some respiratory problems in the clinic are taken to noninvasive mechanical ventilation support and vascular access is required for some treatments to be applied to these newborns. The presence of nasal cannulas used for noninvasive mechanical ventilation support in newborns causes restlessness, agitation and stress in infants. The uneasiness and stress experienced by babies during vascular access also affects effective vascular access, causing other doses to be delayed or skipped due to treatment doses that are not completed on time. In addition, the pain experienced by babies indirectly affects nurses. It has been reported in many studies that it is effective in reducing the pain experienced by newborns with non-pharmacological methods. Simultaneous white noise will be played and therapeutic touch applied to help touch methods and white noise listening help reduce or control newborns' pain. Many studies have shown that touching to and listening white noise is effective in reducing pain. This study was planned as a randomized controlled experimental study to determine the effect of white noise-accompanied therapeutic touch application on pain level and physiological parameters and noninvasive mechanical ventilation support during peripheral intravenous catheterization in premature infants hospitalized for treatment.

Hypothesis 0: The application of therapeutic touch with white noise during peripheral intravenous catheter intervention in premature infants has no effect on the level of pain.

Read more

Hypothesis 1: White noise-accompanied therapeutic touch application reduces pain level during peripheral intravenous catheter intervention in premature infants.

Hypothesis 2: The therapeutic touch application accompanied by white noise during peripheral intravenous catheter intervention in premature infants positively affects physiological parameters.

Read the detailed description

Purpose of the research The study was planned as a randomized controlled experimental study to determine the effect of white noise and therapeutic touch on pain level and physiological parameters and noninvasive mechanical ventilation support during peripheral intravenous catheter intervention in hospitalized premature infants.

As a data collection tool; "Baby Follow-up Form" was used in which some descriptive features of the baby and NIPS and physiological parameter measurements were evaluated.

Application:

The data of the study were collected using simple random sampling method. The newborns to be included in the study were divided into two groups as the intervention group and the control group. The data were determined according to the odd and even numbered days of the calendar between the research dates, and the babies born on the odd numbered days of the calendar were included in the white noise therapeutic touch group (intervention group), and the babies born on the even numbered days of the calendar were included in the control group. The environmental conditions in the two groups were regulated in the same way. The application was carried out with a research nurse performing therapeutic touch, an observer nurse and a practitioner nurse.

Intervention Group (n=40) :

  • Camera recording was started 5 minutes before intravenous catheter intervention, vital signs and pain were evaluated.
  • Therapeutic touch application with white noise was started.
  • Vital signs and pain were evaluated during intravenous catheterization.
  • Vital signs and pain were evaluated when the intravenous catheter intervention was terminated and 5 minutes later, and the camera recording was stopped.

Control Group (n=41):

  • Camera recording was started 5 minutes before the intravenous catheter intervention, vital signs and pain were evaluated.
  • No application was made other than intravascular catheter intervention.
  • Vital signs and pain were evaluated during intravenous catheterization.
  • Vital signs and pain were evaluated when the intravenous catheter intervention was terminated and 5 minutes later, and the camera recording was stopped.

Universe and Research Example Newborns treated at Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital Neonatal Intensive Care Service between June 2021 and January 2022 constitute the population of the research. The sample of the study consisted of 85 newborns meeting the sampling criteria of the study in the Neonatal Intensive Care Service of Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital.

Sampling selection criteria of the infant;

  • 32-36. to be born in gestational weeks,
  • The need for noninvasive mechanical ventilation,
  • Absence of congenital anomalies,
  • Appropriate cognitive level and motor development of the newborn,
  • Does not prevent the opening of the vascular access,
  • Not using narcotic, sedative opioid and anticonvulsant drugs,
  • No pharmacological intervention for the baby's pain during the procedure,
  • Parents sign the informed consent form. Dependent Variables: The newborn's heart rate, respiratory rate, oxygen saturation, body temperature, blood pressure, pain score are the dependent variables.

Independent Variables: The sex of the newborn, gestational age, mode of delivery, weight, height, head circumference, type of feeding, type of noninvasive mechanical ventilation support constitute the independent variables.

Sample size was determined by power analysis. In the study, the power of the sample was calculated with the G*Power 3.1 program. The amount of type I error was 0.05 and the power of the test =0.80 (α=0.05, 1-β=0.80, effect size:0.6), while the minimum sample size (36 newborns in each group) was 72. newborns Considering the losses that may arise from the sample for any reason during the study period, it is planned to take 10% more of the power analysis result. In the study, 40 newborns were included in the intervention group (therapeutic touch with white noise) and 41 newborns in the control group.

Data Collection Written permission from the ethics committee of Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital (Annex-3) and research permission from the Istanbul Governorship Provincial Health Directorate (Annex-4) for the collection of pre-research data. After explanations were given to the families of the newborns who agreed to participate in the study, and to the families of the newborns who met the sample selection criteria for the purpose of the study, verbal and written informed consent was obtained from the families of the newborns who agreed to participate in the study (Annex-1). During the research, personal information will be kept confidential and care will be taken for their privacy. The data of the study were collected between June 2020 and January 2021. The application time of each data and filling the data collection forms took an average of 20-25 minutes.

Evaluation of Data The data of the study were analyzed with appropriate statistical methods using the SPSS (Statistical Package for the Social Science) 22.0 package program. In the evaluation of the data, percentage, number, mean and standard deviation were used as descriptive statistical methods, and frequency and percentage distributions of the data were given. The relationship between the variables measured at the categorical level was evaluated with the Pearson chi-square test. Whether the research variables showed normal distribution or not was examined by paired test and independent group t test. The significance level was 0.05; It was stated that there was a significant difference in cases with p<0.05, and there was no significant difference in cases with p>0.05.

Conditions
Pain
Being tested
Therapeutic touch group accompanied by white noise
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic touch group accompanied by white noiseBehavioural

    During the intravenous catheter intervention, approximately 15-20 minutes of white noise was applied with therapeutic touch.

Study groups in NCT05395208
Study groupRoleWhat they receive
Therapeutic touch group accompanied by white noiseExperimental* Camera recording was started 5 minutes before intravenous catheter intervention, vital signs and pain were evaluated. * Therapeutic touch application with white noise was started. * Vital signs and pain were evaluated during intravenous catheterization. * Vital signs and pain were evaluated when the intravenous catheter intervention was terminated and 5 minutes later, and the camera recording was stopped.
Receives: Behavioral: Therapeutic touch group accompanied by white noise
Control groupNo intervention* Camera recording was started 5 minutes before the intravenous catheter intervention, vital signs and pain were evaluated. * No application was made other than intravascular catheter intervention. * Vital signs and pain were evaluated during intravenous catheterization. * Vital signs and pain were evaluated when the intravenous catheter intervention was terminated and 5 minutes later, and the camera recording was stopped.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Score

    NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

    Measured: Before intravenous catheter intervention (5 minutes ago)

  2. Pain Score

    NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

    Measured: Intravenous catheter attempt sequence (0th. minute)

  3. Pain Score

    NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

    Measured: Immediately after intravenous catheter intervention (0th minute)

  4. Pain Score

    NIPS: Newborn Infant Pain Scale was evaluated. The Newborn Infant Pain Scale consists of 6 behavioral parts: facial expression, crying, breathing pattern, arm and leg movements, and alertness. Apart from crying, 2 separate points (0-1 points) are given for other behaviors, and 3 separate points (0-1-2) are given for crying. The total score varies between 0-7. A high score indicates increased pain intensity. According to the scale scoring: 0 Points: No pain, 1-2 Points: Mild pain, 3-4 Points: Moderate pain, 5-7 Points: Severe pain.

    Measured: 5 minutes after intravenous catheterization

Secondary outcomes (19)
  1. Blood pressure Vital Signs

    Blood pressure (mmHg) were evaluated

    Measured: Before intravenous catheter intervention (5 minutes ago)

  2. Blood pressure Vital Signs

    Blood pressure (mmHg) were evaluated

    Measured: Immediately after intravenous catheter intervention (0th minute)

  3. Blood pressure Vital Signs

    Blood pressure (mmHg) were evaluated

    Measured: 5 minutes after intravenous catheterization

  4. Oxygen saturation Vital Signs

    Oxygen saturation (%) were evaluated

    Measured: Before intravenous catheter intervention (5 minutes ago)

  5. Oxygen saturation Vital Signs

    Oxygen saturation (%) were evaluated

    Measured: Intravenous catheter attempt sequence (0th. minute)

  6. Oxygen saturation Vital Signs

    Oxygen saturation (%) were evaluated

    Measured: Immediately after intravenous catheter intervention (0th minute)

  7. Oxygen saturation Vital Signs

    Oxygen saturation (%) were evaluated

    Measured: 5 minutes after intravenous catheterization

  8. Heart rate Vital Signs

    Heart rate (beats/minute) were evaluated

    Measured: Before intravenous catheter intervention (5 minutes ago)

  9. Heart rate Vital Signs

    Heart rate (beats/minute) were evaluated

    Measured: Intravenous catheter attempt sequence (0th. minute)

  10. Heart rate Vital Signs

    Heart rate (beats/minute) were evaluated

    Measured: Immediately after intravenous catheter intervention (0th minute)

  11. Heart rate Vital Signs

    Heart rate (beats/minute) were evaluated

    Measured: 5 minutes after intravenous catheterization

  12. Respiratory Rate Vital Signs

    Respiratory Rate (breaths/minute) were evaluated

    Measured: Before intravenous catheter intervention (5 minutes ago)

  13. Respiratory Rate Vital Signs

    Respiratory Rate (breaths/minute) were evaluated

    Measured: Intravenous catheter attempt sequence (0th. minute)

  14. Respiratory Rate Vital Signs

    Respiratory Rate (breaths/minute) were evaluated

    Measured: Immediately after intravenous catheter intervention (0th minute)

  15. Respiratory Rate Vital Signs

    Respiratory Rate (breaths/minute) were evaluated

    Measured: 5 minutes after intravenous catheterization

  16. Body temperature Vital Signs

    Body temperature (°C) were evaluated

    Measured: Before intravenous catheter intervention (5 minutes ago)

  17. Body temperature Vital Signs

    Body temperature (°C) were evaluated

    Measured: Intravenous catheter attempt sequence (0th. minute)

  18. Body temperature Vital Signs

    Body temperature (°C) were evaluated

    Measured: Immediately after intravenous catheter intervention (0th minute)

  19. Body temperature Vital Signs

    Body temperature (°C) were evaluated

    Measured: 5 minutes after intravenous catheterization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start1 Jun 2021
  3. Primary completion15 Dec 2021
  4. Study completion12 Jan 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled two groups (control groups and intervention group)
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395208
Sponsor's protocol ID
2021/99
Status last verified
May 2022
First submitted
12 May 2022
Last updated
27 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic touch group accompanied by white noise in people with Pain, run by Okan University 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 7 inclusion and 5 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 27 May 2022. 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?

Pain Score (time frame: Before intravenous catheter intervention (5 minutes ago)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 May 2022.

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