Trial Outcomes & Findings for Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants (NCT NCT01495286)

Results Overview

Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.

Results posted on

2012-11-19

Participant Flow

Recruitment period started 12/15/11, ended 06/21/12. All recruitment took place in the well mothers and babies (rooming-in) unit at the University of Arkansas Medical Center (UAMS). Parents of infants were contacted in their individual rooms by research staff and parents signed IRB -approved consents if they wanted their infants to participate.

The parents of one infant signed the consent form but then changed their minds before the infant actually participated in the study. This infant was withdrawn from the study.

Participant milestones

Participant milestones
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety of Noninvasive Electrical Stimulation of Acupuncture Points (NESAP) in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n=30 Participants This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Age, Categorical <=18 years	30 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	1 days STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.

Population: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.

Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.

Outcome measures

Outcome measures
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n=30 Participants This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Heart Rate During Treatment With TENS Unit Baseline heart rate	137 beats per minute Standard Deviation 11.9
Heart Rate During Treatment With TENS Unit Heart rate after 5 minutes of NESAP	131 beats per minute Standard Deviation 15
Heart Rate During Treatment With TENS Unit Heart rate 5 minutes after heelstick	133 beats per minute Standard Deviation 15
Heart Rate During Treatment With TENS Unit Heart rate after return to room	133 beats per minute Standard Deviation 15

PRIMARY outcome

Timeframe: Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.

Population: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant increase in pain level. With 30 infants, we had 90% power to detect a significant increase in PIPP score with a .05 level, one-sided paired t-test.

Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.

Outcome measures

Outcome measures
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n=30 Participants This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick Oxygen saturation before NESAP	98 percentage of oxygen saturation Standard Deviation 1.55
Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick Oxygen saturation after 5 minutes of NESAP	97 percentage of oxygen saturation Standard Deviation 2.18
Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick Oxygen saturation 5 minutes after heel stick	96 percentage of oxygen saturation Standard Deviation 2.3

SECONDARY outcome

Timeframe: Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.

Population: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.

Changes in systolic and diastolic blood pressure after initial baseline. Measurements will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.

Outcome measures

Outcome measures
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n=30 Participants This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Blood Pressure During TENS Treatment and Heel Stick Systolic blood pressure before NESAP	85 mm Hg Standard Deviation 13
Blood Pressure During TENS Treatment and Heel Stick Systolic blood pressure after 5 minutes NESAP	84 mm Hg Standard Deviation 12
Blood Pressure During TENS Treatment and Heel Stick Systolic blood pressure after return to room	83 mm Hg Standard Deviation 10
Blood Pressure During TENS Treatment and Heel Stick Systolic blood pressure 5 minutes after heel stick	84 mm Hg Standard Deviation 13

SECONDARY outcome

Timeframe: Pain score given during the heel stick process and for 2 minutes afterwards

Population: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.

Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.

Outcome measures

Outcome measures
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n=30 Participants This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) before NESAP	2.17 units on a scale Standard Deviation 1.72
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) after TENS unit turned on	2.8 units on a scale Standard Deviation 2.14
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) after 10 minutes of NESAP	1.57 units on a scale Standard Deviation 1.3
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) during heel cleaning	3.17 units on a scale Standard Deviation 2.09
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) during heel stick	8.88 units on a scale Standard Deviation 4.26
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) during heel squeeze	8.13 units on a scale Standard Deviation 4.2
Pain During TENS Treatment and Routine Heel Stick Pain score (PIPP) during recovery	4.32 units on a scale Standard Deviation 3.76

SECONDARY outcome

Timeframe: Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.

Population: We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants,we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one sided paired t test

Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.

Outcome measures

Outcome measures
Measure	Noninvasive Electrical Stimulation Acupuncture Points (NESAP) n=30 Participants This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
Skin Assessment Baseline assessment for skin irritation	0 participants
Skin Assessment Skin irritation upon discharge	0 participants
Skin Assessment Skin irritation after one week	0 participants
Skin Assessment Skin irritation after NESAP	0 participants

Adverse Events

Noninvasive Electrical Stimulation Acupuncture Points (NESAP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anita Mitchell PhD, coinvestigator

University of Arkansas

Phone: 501-686-7021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place